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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. (APOLLO)

Primary Purpose

Mitral Valve Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Heart disease, valve disease, heart valve disease, mitral regurgitation, cardiovascular disease, mitral insufficiency

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria:

  • prior transcatheter mitral valve procedure with device currently implanted
  • anatomic contraindications
  • prohibitive mitral annular calcification
  • left ventricular ejection fraction <30%
  • need for emergent or urgent surgery
  • hemodynamic instability

Sites / Locations

  • University of Alabama Birmingham (UAB)Recruiting
  • Abrazo Heart HospitalRecruiting
  • Scripps Memorial HospitalRecruiting
  • PIH Health Good Samaritan HospitalRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Keck Hospital of the University of Southern CaliforniaRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • El CaminoRecruiting
  • Kaiser Permanente San Francisco Medical CenterRecruiting
  • Stanford Hospital and ClinicsRecruiting
  • Los Robles Regional Medical CenterRecruiting
  • Hartford HospitalRecruiting
  • Yale New Haven HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • JFK Medical CenterRecruiting
  • Morton PlantRecruiting
  • HealthPark Medical CenterRecruiting
  • North Florida Regional Medical CenterRecruiting
  • Baptist Medical Center JacksonvilleRecruiting
  • Emory UniversityRecruiting
  • Piedmont Atlanta HospitalRecruiting
  • Northwestern Memorial HospitalRecruiting
  • Rush University Medical CenterRecruiting
  • Mercy Medical CenterRecruiting
  • The University of Kansas HospitalRecruiting
  • University of Maryland Medical CenterRecruiting
  • The Johns Hopkins Hospital
  • Massachusetts General HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of Michigan Health SystemRecruiting
  • Ascension St. John HospitalRecruiting
  • Spectrum Health HospitalRecruiting
  • University of Minnesota Medical Center FairviewRecruiting
  • Barnes-Jewish HospitalRecruiting
  • Providence St PatrickRecruiting
  • Providence St Patrick
  • Morristown Memorial HospitalRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • North Shore University HospitalRecruiting
  • NYU Langone Hospital - Long IslandRecruiting
  • NYU Langone Medical CenterRecruiting
  • The Mount Sinai HospitalRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • Montefiore Medical CenterRecruiting
  • Saint Francis HospitalRecruiting
  • Duke University Medical CenterRecruiting
  • The Christ HospitalRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • OhioHealth Riverside Methodist HospitalRecruiting
  • INTEGRIS Baptist Medical CenterRecruiting
  • Providence Saint Vincent Medical CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • UPMC Pinnacle Harrisburg CampusRecruiting
  • University of Pittsburgh Medical Center UPMC PresbyterianRecruiting
  • Lankenau Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Heart Hospital of AustinRecruiting
  • Texas Health Presbyterian Hospital DallasRecruiting
  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
  • CHI Saint Luke's Health-Baylor Saint Luke's Medical CenterRecruiting
  • Houston Methodist Hospital
  • The University of Texas Health Science Center at HoustonRecruiting
  • Baylor Scott & White Health (The Heart Hospital Baylor Plano)Recruiting
  • Methodist HospitalRecruiting
  • The University of Vermont Medical CenterRecruiting
  • University of Virginia Medical Center
  • Inova Fairfax HospitalRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Saint Mary's Hospital/Bon Secours
  • Carilion Roanoke Memorial HospitalRecruiting
  • Winchester Medical Center
  • The Swedish Medical Center Cherry Hill
  • University of WashingtonRecruiting
  • Providence Sacred Heart Medical Center & Children's HospitalRecruiting
  • Aurora St. Luke's Medical CenterRecruiting
  • Royal Columbian HospitalRecruiting
  • St. Paul's HospitalRecruiting
  • Sunnybrook Health Sciences Centre
  • St. Michael's HospitalRecruiting
  • Montreal Heart InsituteRecruiting
  • Glen Royal victoria HospitalRecruiting
  • Glen Royal VictoriaRecruiting
  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary Cohort- TMVR

Mitral Annular Calcification -TMVR

Arm Description

Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)

Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)

Outcomes

Primary Outcome Measures

Primary Cohort
all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite
MAC Cohort
all-cause mortality and heart failure hospitalization composite

Secondary Outcome Measures

all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
Composite
Change in New York Heart Association Class
change in NYHA Class
Quality of Life Improvement
measured by SF-12 and KCCQ
Echocardiographic assessments of degree mitral valve regurgitation
measured by echocardiography
Cardiovascular hospitalizations
cardiovascular hospitalizations

Full Information

First Posted
August 3, 2017
Last Updated
October 10, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT03242642
Brief Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Acronym
APOLLO
Official Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
October 30, 2026 (Anticipated)
Study Completion Date
September 30, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

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

5. Study Description

Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
Heart disease, valve disease, heart valve disease, mitral regurgitation, cardiovascular disease, mitral insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Cohort- TMVR
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Arm Title
Mitral Annular Calcification -TMVR
Arm Type
Experimental
Arm Description
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Intervention Type
Device
Intervention Name(s)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Intervention Description
mitral valve replacement
Intervention Type
Device
Intervention Name(s)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Intervention Description
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Primary Outcome Measure Information:
Title
Primary Cohort
Description
all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite
Time Frame
1 year
Title
MAC Cohort
Description
all-cause mortality and heart failure hospitalization composite
Time Frame
1 year
Secondary Outcome Measure Information:
Title
all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
Description
Composite
Time Frame
30 days or hospital discharge (whichever is later)
Title
Change in New York Heart Association Class
Description
change in NYHA Class
Time Frame
30 days
Title
Quality of Life Improvement
Description
measured by SF-12 and KCCQ
Time Frame
30 days (SF-12) and 3 months (KCCQ)
Title
Echocardiographic assessments of degree mitral valve regurgitation
Description
measured by echocardiography
Time Frame
1 year
Title
Cardiovascular hospitalizations
Description
cardiovascular hospitalizations
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe or severe symptomatic mitral regurgitation Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention Exclusion Criteria: prior transcatheter mitral valve procedure with device currently implanted anatomic contraindications prohibitive mitral annular calcification left ventricular ejection fraction <30% need for emergent or urgent surgery hemodynamic instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Wilder Fredrickson
Phone
7635289970
Email
rs.tmvrpivotaltrial@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mack, MD
Organizational Affiliation
Baylor Scott & White Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Adams, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Leon, MD
Organizational Affiliation
New York Presbyterian Hospital/Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham (UAB)
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
Mustafa Ahmed
Facility Name
Abrazo Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Byrne, MD
First Name & Middle Initial & Last Name & Degree
Merick Kirshner, MD
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Brewster, MD
First Name & Middle Initial & Last Name & Degree
Matthew Price, MD
Facility Name
PIH Health Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Burstein
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somjot Brar, MD
First Name & Middle Initial & Last Name & Degree
Blanding Jones, MD
Facility Name
Keck Hospital of the University of Southern California
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
Vaughn Starnes, MD
First Name & Middle Initial & Last Name & Degree
Ray Vern Matthews, 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
Saibal Kar, MD
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
First Name & Middle Initial & Last Name & Degree
Danny Ramzy, MD
Facility Name
El Camino
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Rammohan, MD
Facility Name
Kaiser Permanente San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118-3100
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Sheikh, MD
First Name & Middle Initial & Last Name & Degree
Andrew Rassi, MD
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lee, MD
First Name & Middle Initial & Last Name & Degree
Jack Boyd, MD
Facility Name
Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-1847
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saibal Kar
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talhat Azemi, MD
First Name & Middle Initial & Last Name & Degree
Sabet Hashim
First Name & Middle Initial & Last Name & Degree
Robert Hagberg
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John K Forrest, MD
First Name & Middle Initial & Last Name & Degree
Prashanth Vallabhajosyula, MD
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Waksman, MD
First Name & Middle Initial & Last Name & Degree
Christian Shults, MD
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Rothenberg, MD
First Name & Middle Initial & Last Name & Degree
Marcos Nores, MD
Facility Name
Morton Plant
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
Lang L Lin, MD
First Name & Middle Initial & Last Name & Degree
Joshua J Rovin, MD
Facility Name
HealthPark Medical Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murali Muppala, MD
First Name & Middle Initial & Last Name & Degree
Michael DeFrain, MD
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
Ilie Barb, MD
First Name & Middle Initial & Last Name & Degree
Charles Klodell, MD
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruby Satpahy
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Greenbaum
Facility Name
Piedmont Atlanta Hospital
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
Pradeep Yadav, MD
First Name & Middle Initial & Last Name & Degree
Thourani Vinod, MD
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris S Malaisrie, MD
First Name & Middle Initial & Last Name & Degree
Charles Davidson, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hussam Suradi, MD
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atul Chawla, MD
First Name & Middle Initial & Last Name & Degree
Bart Jenson, MD
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Wiley, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel Daon, MD
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
Mark M Vesely, MD
First Name & Middle Initial & Last Name & Degree
Bradley Taylor, MD
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Inglessis, MD
First Name & Middle Initial & Last Name & Degree
Serguei Melnitchouk, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinak Bipin Shah, MD
First Name & Middle Initial & Last Name & Degree
Mark Cunningham, MD
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
Laham Roger
Facility Name
University of Michigan Health System
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
Stanley Chetcuti, MD
First Name & Middle Initial & Last Name & Degree
Steven Bolling, MD
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Schreiber
First Name & Middle Initial & Last Name & Degree
Sanjay Batra
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Merhi, MD
First Name & Middle Initial & Last Name & Degree
Stephane Leung Wai Sang, MD
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Helmer
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Zajarias, MD
First Name & Middle Initial & Last Name & Degree
Puja Kachroo, MD
Facility Name
Providence St Patrick
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802-4008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Spoon
Facility Name
Providence St Patrick
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802-4008
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Travis Abicht
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Genereux, MD
First Name & Middle Initial & Last Name & Degree
John Brown, MD
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Saybolt
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Rutkin, MD
First Name & Middle Initial & Last Name & Degree
Sheel Vatsia, MD
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Schwartz, MD
First Name & Middle Initial & Last Name & Degree
Khaled Salhab, MD
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Williams, MD
First Name & Middle Initial & Last Name & Degree
Cezar Staniloae, MD
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samin Sharma, MD
First Name & Middle Initial & Last Name & Degree
David Adams, MD
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
First Name & Middle Initial & Last Name & Degree
Isaac George, MD
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467-2401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azeem Latib
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Petrossian, MD
First Name & Middle Initial & Last Name & Degree
Newell Robinson, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Kevin Harrison, MD
First Name & Middle Initial & Last Name & Degree
Carmelo Milano, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Choo, MD
First Name & Middle Initial & Last Name & Degree
Geoffrey Answini, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme Attizzani, MD
First Name & Middle Initial & Last Name & Degree
Alan Markowitz, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Boudoulas, MD
First Name & Middle Initial & Last Name & Degree
Bryan Whitson, MD
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, MD
First Name & Middle Initial & Last Name & Degree
Steven Duff, MD
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Fife
First Name & Middle Initial & Last Name & Degree
Jeffrey Sparling, MD
First Name & Middle Initial & Last Name & Degree
Craig Elkins, MD
Facility Name
Providence Saint Vincent Medical Center
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
Ethan Korngold, MD
First Name & Middle Initial & Last Name & Degree
Eric Kirker, MD
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Zahr, MD
First Name & Middle Initial & Last Name & Degree
Howard Song, MD
Facility Name
UPMC Pinnacle Harrisburg Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemal Gada, MD
First Name & Middle Initial & Last Name & Degree
Mubashir Mumtaz, MD
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Sultan, MD
First Name & Middle Initial & Last Name & Degree
Conrad Smith, MD
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott S Goldman, MD
First Name & Middle Initial & Last Name & Degree
William W Gray, MD
First Name & Middle Initial & Last Name & Degree
Basel Ramlawi, MD
Facility Name
Vanderbilt University 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
Ashish Shah, MD
First Name & Middle Initial & Last Name & Degree
Colin Barker, MD
First Name & Middle Initial & Last Name & Degree
Brian Lindman, MD
Facility Name
Heart Hospital of Austin
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
Juhana Karha, MD
First Name & Middle Initial & Last Name & Degree
Faraz Kerendi, MD
Facility Name
Texas Health Presbyterian Hospital Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Park
First Name & Middle Initial & Last Name & Degree
Brandon Hill
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Withdrawn
Facility Name
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
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
Guilherme Silva, MD
First Name & Middle Initial & Last Name & Degree
Joseph Coselli, MD
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas Health Science Center at Houston
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
Richard Smalling, MD
First Name & Middle Initial & Last Name & Degree
Anthony Estrera, MD
Facility Name
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Szerlip
First Name & Middle Initial & Last Name & Degree
Robert Smith
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Alvarez, MD
First Name & Middle Initial & Last Name & Degree
Brent New, MD
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold Dauerman
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahram Yazdani, MD
First Name & Middle Initial & Last Name & Degree
Eric Sarin, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Summers, MD
Facility Name
Saint Mary's Hospital/Bon Secours
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Withdrawn
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Foerst, MD
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Swedish Medical Center Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James McCabe
Facility Name
Providence Sacred Heart Medical Center & Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Huber, MD
First Name & Middle Initial & Last Name & Degree
Matthew Forrester, MD
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanvir Bajwa, MD
First Name & Middle Initial & Last Name & Degree
Eric Weiss, MD
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khan Razi
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wood David
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Active, not recruiting
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
Neil Fam
First Name & Middle Initial & Last Name & Degree
Gianluigi Bisleri
Facility Name
Montreal Heart Insitute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Asgar
Facility Name
Glen 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
Nicolo Piazza
Facility Name
Glen Royal Victoria
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
Nicolo Piazza
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Learn more about this trial

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

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