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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

Primary Purpose

Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tendyne Mitral Valve System
MitraClip System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
  • NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
  • The local site heart team determines that the subject has been adequately treated per applicable standards
  • Not a member of a vulnerable population

Exclusion Criteria:

  • Mitral valvular vegetation or mass
  • Left ventricular ejection fraction < 25%
  • Left ventricular end diastolic diameter > 7.0 cm
  • Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
  • Aortic valve disease requiring surgery or transcatheter intervention
  • Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
  • Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
  • Subject undergoing hemodialysis due to chronic renal failure
  • Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
  • Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Sites / Locations

  • Princeton Baptist Medical Center
  • UAB University HospitalRecruiting
  • Banner-University Medical CenterRecruiting
  • HonorHealth Scottsdale Shea Medical CenterRecruiting
  • Fresno Heart HospitalRecruiting
  • University of Southern California University HospitalRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Sutter Medical Center, SacramentoRecruiting
  • University of California - Davis Medical CenterRecruiting
  • San Diego Cardiac CenterRecruiting
  • University of California at San FranciscoRecruiting
  • Stanford Health CareRecruiting
  • Los Robles Hospital and Medical CenterRecruiting
  • University of Colorado Hospital
  • Manatee Memorial HospitalRecruiting
  • Morton Plant HospitalRecruiting
  • Delray Medical Center
  • North Florida Regional Medical CenterRecruiting
  • Shands at the University of FloridaRecruiting
  • Baptist Hospital of MiamiRecruiting
  • Tallahassee Research InstituteRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Piedmont Heart InstituteRecruiting
  • Emory University HospitalRecruiting
  • Wellstar Kennestone HospitalRecruiting
  • St. Alphonsus Regional Medical CenterRecruiting
  • Rush University Medical CenterRecruiting
  • Advocate Christ Medical CenterRecruiting
  • Prairie Education & Research CooperativeRecruiting
  • St. Vincent HospitalRecruiting
  • Cardiovascular Research Institute of KansasRecruiting
  • University of Maryland Medical CenterRecruiting
  • Medstar Health Research InstituteRecruiting
  • Adventist HealthCare White Oak Medical Center
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of MichiganRecruiting
  • Henry Ford HospitalRecruiting
  • Beaumont Hospital
  • Abbott Northwestern HospitalRecruiting
  • Mayo ClinicRecruiting
  • St. Luke's HospitalRecruiting
  • St. Louis University HospitalRecruiting
  • The International Heart Institute of MontanaRecruiting
  • Catholic Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Robert Wood Johnson University HospitalRecruiting
  • Newark Beth Israel Medical CenterRecruiting
  • Albany Medical College at Albany Medical CenterRecruiting
  • Southside Hospital- Northwell HealthRecruiting
  • Buffalo General HospitalRecruiting
  • New York Presbyterian Hospital/ Weill Cornell Medical CenterRecruiting
  • Lenox Hill HospitalRecruiting
  • Mission Health & HospitalsRecruiting
  • Carolinas Medical CenterRecruiting
  • Novant Health Heart and Vascular Research InstituteRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • Oklahoma Heart Institute at UticaRecruiting
  • Providence Heart & Vascular InstituteRecruiting
  • Alleghany General Hospital - ASRIRecruiting
  • UPMC ShadysideRecruiting
  • Medical University of South CarolinaRecruiting
  • Baptist Memorial HospitalRecruiting
  • Centennial Medical CenterRecruiting
  • St. Thomas HospitalRecruiting
  • Cardiothoracic & Vascular SurgeonsRecruiting
  • Baylor Scott & White Heart and Vascular HospitalRecruiting
  • Medical City Dallas HospitalRecruiting
  • Memorial Hermann HospitalRecruiting
  • University of Virginia Medical CenterRecruiting
  • Inova Fairfax HospitalRecruiting
  • Swedish Medical Center - Heart & VascularRecruiting
  • West Virginia UniversityRecruiting
  • Medical College of Wisconsin
  • Ottawa Heart InstituteRecruiting
  • St. Michael's HospitalRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • The Royal Victoria HospitalRecruiting
  • Montreal Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Randomized Cohort - Treatment Group

Randomized Cohort - Control Group

Non-repairable Cohort

Severe Mitral Annular Calcification (MAC) Cohort

Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort

Arm Description

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Treatment of mitral regurgitation within commercially approved MitraClip system indications

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort

Outcomes

Primary Outcome Measures

Randomized Cohort
Survival free of heart failure hospitalization at 12 months post index procedure
Non-repairable Cohort
Survival free of heart failure hospitalization at 12 months post index procedure
Severe Mitral Annular Calcification (MAC) Cohort
Survival free of heart failure hospitalization at 12 months post index procedure
Severe MAC Continued Access Protocol (MAC CAP) Cohort
Survival free of heart failure hospitalization at 12 months post index procedure

Secondary Outcome Measures

Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)
Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change from baseline in health outcomes, as measured by the EQ-5D
• Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)
Change from baseline in New York Heart Association Classification

Full Information

First Posted
February 8, 2018
Last Updated
July 7, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT03433274
Brief Title
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Acronym
SUMMIT
Official Title
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease, Heart, Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
958 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized Cohort - Treatment Group
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Arm Title
Randomized Cohort - Control Group
Arm Type
Active Comparator
Arm Description
Treatment of mitral regurgitation within commercially approved MitraClip system indications
Arm Title
Non-repairable Cohort
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Arm Title
Severe Mitral Annular Calcification (MAC) Cohort
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
Arm Title
Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort
Intervention Type
Device
Intervention Name(s)
Tendyne Mitral Valve System
Intervention Description
Mitral valve replacement
Intervention Type
Device
Intervention Name(s)
MitraClip System
Intervention Description
Percutaneous mitral valve repair using the MitraClip system.
Primary Outcome Measure Information:
Title
Randomized Cohort
Description
Survival free of heart failure hospitalization at 12 months post index procedure
Time Frame
1 year
Title
Non-repairable Cohort
Description
Survival free of heart failure hospitalization at 12 months post index procedure
Time Frame
1 year
Title
Severe Mitral Annular Calcification (MAC) Cohort
Description
Survival free of heart failure hospitalization at 12 months post index procedure
Time Frame
1 year
Title
Severe MAC Continued Access Protocol (MAC CAP) Cohort
Description
Survival free of heart failure hospitalization at 12 months post index procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)
Time Frame
1 year
Title
Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
1 year
Title
Change from baseline in health outcomes, as measured by the EQ-5D
Time Frame
1 year
Title
• Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)
Time Frame
1 year
Title
Change from baseline in New York Heart Association Classification
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC) NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory) The local site heart team determines that the subject has been adequately treated per applicable standards Not a member of a vulnerable population Exclusion Criteria: Mitral valvular vegetation or mass Left ventricular ejection fraction < 25% Left ventricular end diastolic diameter > 7.0 cm Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material Aortic valve disease requiring surgery or transcatheter intervention Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention Any planned surgical / interventional procedure within 60 day prior to or following subject randomization Subject undergoing hemodialysis due to chronic renal failure Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Dellefratte
Phone
+1 (669)214-9748
Email
SUMMIT.Trial@abbott.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Ornelas
Phone
+1 (602)692-5047
Email
leslie.ornelas@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Rogers, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan Palmer, PhD
Organizational Affiliation
Abbott Structural Heart
Official's Role
Study Director
Facility Information:
Facility Name
Princeton Baptist Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Individual Site Status
Terminated
Facility Name
UAB University Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Phillips
Email
kcphillips@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, M.D.
Facility Name
Banner-University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew Freeman
Email
Mathew.Freeman@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Philip Gideon, M.D.
Facility Name
HonorHealth Scottsdale Shea Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Gaughan
Email
agaughan@honorhealth.com
First Name & Middle Initial & Last Name & Degree
David Rizik, M.D.
Facility Name
Fresno Heart Hospital
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Biggs
Email
lbiggs@communitymedical.org
First Name & Middle Initial & Last Name & Degree
Shamsuddin Khwaja, M.D.
Facility Name
University of Southern California University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Mullin
Email
Stephanie.Mullin@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Praeger, MD
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Yashar
Email
Jason.Yashar@cshs.org
First Name & Middle Initial & Last Name & Degree
Raj Makkar, M.D.
Facility Name
Sutter Medical Center, Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Mccall
Email
jessica.mccall@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
David Roberts, M.D.
Facility Name
University of California - Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberley Book
Email
kabook@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Jason Rogers, M.D.
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Van Tol
Email
cvantol@sdcardiac.com
First Name & Middle Initial & Last Name & Degree
Raghava Gollapudi, M.D.
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Ku
Email
Jason.Ku@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Sammy Elmariah, M.D.
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Zhang
Email
jianhaoz@stanford.edu
First Name & Middle Initial & Last Name & Degree
Rahul Sharma, M.D.
Facility Name
Los Robles Hospital and Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mane Arabyan
Email
Mane.arabyan@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Gregory Fontana, M.D.
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Terminated
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savannah Peterson
Email
Savannah.Peterson@mmhhs.com
First Name & Middle Initial & Last Name & Degree
Alessandro Golino, M.D.
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Fisher
Email
Susan.Fisher1@baycare.org
First Name & Middle Initial & Last Name & Degree
Joshua Rovin, M.D.
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Terminated
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Touchton
Email
atouchton@tcavi.com
First Name & Middle Initial & Last Name & Degree
Charles Klodell, M.D.
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Cobb
Email
jessica.cobb@surgery.ufl.edu
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, M.D.
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ines Ardid
Email
MariaAr@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Ramon Quesada, M.D.
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Porter
Email
Dana.Porter@tmh.org
First Name & Middle Initial & Last Name & Degree
Thomas Noel, M.D.
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Mejia-Gomez
Email
mejiagm@ccf.org
First Name & Middle Initial & Last Name & Degree
Jose Navia, M.D.
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, M.D.
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittney Truss
Email
Brittney.Truss@piedmont.org
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, M.D.
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, M.D.
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kaner
Email
maria.kaner@emory.edu
First Name & Middle Initial & Last Name & Degree
Vasilis Babaliaros, M.D.
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Cuvo
Email
Jennifer.Cuvo@wellstar.org
First Name & Middle Initial & Last Name & Degree
Amar Patel, MD
Facility Name
St. Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Furlipa
Email
Joy.Furlipa@saintalphonsus.org
First Name & Middle Initial & Last Name & Degree
Robert Farivar, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ann Donahue
Email
mary_a_donahue@rush.edu
First Name & Middle Initial & Last Name & Degree
Clifford Kavinsky, MD
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Gallagher
Email
colleen.gallagher@aah.org
First Name & Middle Initial & Last Name & Degree
Ravi Ramana, M.D.
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Hudson
Email
shudson@prairieresearch.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Goldstein, M.D.
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Willard
Email
hannah.jenkins1@ascension.org
First Name & Middle Initial & Last Name & Degree
Sina Moainie, M.D.
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Thunberg
Email
Meredith.thunberg@cckheart.com
First Name & Middle Initial & Last Name & Degree
Bassem Chehab, M.D.
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shantel Sosa
Email
ssosa@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Bradley Taylor, M.D.
Facility Name
Medstar Health Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Moyer
Email
keith.t.moyer@medstar.net
First Name & Middle Initial & Last Name & Degree
Brian Bethea, M.D.
Facility Name
Adventist HealthCare White Oak Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Individual Site Status
Terminated
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenifer Kaufman
Email
jmkaufma@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Roger Laham, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Rupar
Email
soavek@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Matthew Romano, M.D.
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi, M.D.
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Holmes
Email
dholmes7@hfhs.org
First Name & Middle Initial & Last Name & Degree
Tiberio Frisoli, M.D.
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Withdrawn
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Olson
Email
Sara.Olson@allina.com
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, M.D.
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Griffin II
Email
GriffinII.carl@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mayra Guerrero, MD
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Ramsey
Email
ambramsey1@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Keith Allen, M.D.
Facility Name
St. Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Lesko
Email
mary.lesko@health.slu.edu
First Name & Middle Initial & Last Name & Degree
Kishore Harjai, M.D.
Facility Name
The International Heart Institute of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Michael
Email
Christina.Michael@providence.org
First Name & Middle Initial & Last Name & Degree
James Maddux, M.D.
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Driscoll
Email
Jennifer.driscoll@cmc-nh.org
First Name & Middle Initial & Last Name & Degree
Fahad Gilani, M.D.
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Castillo
Email
Manuel.Castillo@hmhn.org
First Name & Middle Initial & Last Name & Degree
Tilak Pasala, M.D.
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Smith
Email
ms3008@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Mark Russo, M.D.
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Policastro
Email
Patricia.Policastro@rwjbh.org
First Name & Middle Initial & Last Name & Degree
Arash Salemi, M.D.
Facility Name
Albany Medical College at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Belenchia
Email
belencr@amc.edu
First Name & Middle Initial & Last Name & Degree
Sanjay Samy, M.D.
Facility Name
Southside Hospital- Northwell Health
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Annunziato
Email
sannunziato@northwell.edu
First Name & Middle Initial & Last Name & Degree
Robert Kalimi, M.D.
Facility Name
Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Bishop
Email
cabishop@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, M.D.
Facility Name
New York Presbyterian Hospital/ Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshagay Rodriques
Email
mar4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Mick, M.D.
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efstathia Mihelis
Email
EMihelis@northwell.edu
First Name & Middle Initial & Last Name & Degree
Robert Kalimi, M.D.
First Name & Middle Initial & Last Name & Degree
Chad Kliger, M.D.
Facility Name
Mission Health & Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Riggsbee
Email
christina.riggsbee@HCAHealthcare.com
First Name & Middle Initial & Last Name & Degree
Mark Groh, M.D.
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montana Bright
Email
montana.bright@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Michael Rinaldi, M.D.
Facility Name
Novant Health Heart and Vascular Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Clontz
Email
aclontz@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Oluseun Alli, M.D.
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachael Mardis
Email
mardisrl@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Imran Arif, MD
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madelyn Espen
Email
espenm@ccf.org
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, M.D.
Facility Name
Oklahoma Heart Institute at Utica
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Sconyers
Email
angela.sconyers@oklahomaheart.com
First Name & Middle Initial & Last Name & Degree
Kamran Muhammad, M.D.
Facility Name
Providence Heart & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Jackson
Email
sarah.jackson3@providence.org
First Name & Middle Initial & Last Name & Degree
Brandon Jones, M.D.
Facility Name
Alleghany General Hospital - ASRI
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Spirk
Email
Tracy.Spirk@ahn.org
First Name & Middle Initial & Last Name & Degree
Walter McGregor, M.D.
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Sanders Linger
Email
sanderslingerm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Anson Smith, M.D.
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Schorr
Email
schorr@musc.edu
First Name & Middle Initial & Last Name & Degree
Marc Katz, M.D.
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Jackson
Email
leigh.jackson@sterncardio.com
First Name & Middle Initial & Last Name & Degree
Basil Paulus, M.D.
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Bozarth
Email
lauren.bozarth@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Sreekumar Subramanian, M.D.
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikole Gasaway
Email
nikole.minnick@ascension.org
First Name & Middle Initial & Last Name & Degree
Evelio Rodriguez, M.D.
Facility Name
Cardiothoracic & Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcedes Coffman
Email
MCoffman@ctvstexas.com
First Name & Middle Initial & Last Name & Degree
Faraz Kerendi, M.D.
Facility Name
Baylor Scott & White Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Aston
Email
Susan.Aston@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Robert Hebeler, M.D.
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Prince
Email
Brandon.Prince2@scresearch.net
First Name & Middle Initial & Last Name & Degree
Bruce Bowers, M.D.
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Layton
Email
Taylor.Layton.1@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sukhdeep Basra, M.D.
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Lloyd, RN
Email
rcl4m@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
David Lim, M.D.
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Moore
Email
Brian.Moore@inova.org
First Name & Middle Initial & Last Name & Degree
Wayne Batchelor, M.D.
Facility Name
Swedish Medical Center - Heart & Vascular
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Garcia
Email
michelle.garcia@swedish.org
First Name & Middle Initial & Last Name & Degree
Sameer Gafoor, M.D.
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Bombard
Email
josh.bombard@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
Vinay Badhwar, M.D.
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Terminated
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Robinson
Email
LiRobinson@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, M.D.
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana Kandic
Email
Ivana.Kandic@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Neil Fam, M.D.
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Li
Email
mary.li@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Gideon Cohen, M.D.
Facility Name
The Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thi Mong Ngoc Phan
Email
thimongngoc.phan@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Nicolo Piazza, M.D.
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Moisan
Email
natasha.moisan@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Anita Asgar, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

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