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Evolut™ EXPAND TAVR II Pivotal Trial

Primary Purpose

Aortic Stenosis Symptomatic, Moderate Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis Symptomatic focused on measuring aortic, stenosis, symptomatic, moderate, valve, TAVR

Eligibility Criteria

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

Key Inclusion Criteria:

  • Moderate AS, defined as follows by transthoracic echo (TTE) at rest:

    • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, and
    • Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, and
    • AVA >1.0 cm2 and < 1.5 cm2

  • NYHA class ≥ II and symptoms of AS, including but not limited to:

    • Dyspnea at rest or on exertion
    • Fatigue
    • Angina
    • Syncope in the absence of another identifiable cause
  • LVEF > 20% by 2-D echo

  • Any of the following

    • HF event or hospitalization for heart failure within 1 calendar year prior to qualifying echo
    • NT proBNP ≥ 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or within 2 weeks after qualifying echo,
    • Global longitudinal strain ≤15% (absolute value) at qualifying echo, or
    • E/e' (average of medial and lateral velocities) ≥ 14.0 at qualifying echo

Key Exclusion Criteria:

  • Age < 65 years
  • Class I indication for cardiac surgery
  • Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
  • Not anatomically suitable for transfemoral TAVR with the trial device
  • In need of and suitable for coronary revascularization per Heart Valve Team
  • Documented history of cardiac amyloidosis

Sites / Locations

  • University of Alabama at Birmingham (UAB) HospitalRecruiting
  • Abrazo Arizone Heart HospitalRecruiting
  • HonorHealth Scottsdale Shea Medical CenterRecruiting
  • Los Robles Hospital & Medical CenterRecruiting
  • University of Colorado HospitalRecruiting
  • Saint Vincents Medical CenterRecruiting
  • Hartford HospitalRecruiting
  • Morton Plant HospitalRecruiting
  • University of FloridaRecruiting
  • Saint Vincent's Medical Center RiversideRecruiting
  • Tallahassee Memorial HospitalRecruiting
  • Tampa General HospitalRecruiting
  • Terrebonne General Medical CenterRecruiting
  • The Johns Hopkins HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Baystate Medical CenterRecruiting
  • University of Michigan Health System - University HospitalRecruiting
  • Ascension Saint John HospitalRecruiting
  • Spectrum HealthRecruiting
  • Abbott Northwestern HospitalRecruiting
  • Mayo ClinicRecruiting
  • SSM Health Saint Louis University HospitalRecruiting
  • Catholic Medical CenterRecruiting
  • Northwell HealthRecruiting
  • The Mount Sinai HospitalRecruiting
  • Mission HospitalRecruiting
  • Wake Forest University Heatlh SciencesRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Kettering Health Main CampusRecruiting
  • Integris Baptist Medical CenterRecruiting
  • Oregon Health & Science University HospitalRecruiting
  • Lehigh Valley Hospital, IncRecruiting
  • UPMC Pinnacle Harrisburg CampusRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • Monument Health Rapid City HospitalRecruiting
  • Erlanger Medical CenterRecruiting
  • Baylor Jack and Jane Hamilton Heart and Vascular HospitalRecruiting
  • Medical City DallasRecruiting
  • Texas Health Harris Methodist Hospital Fort WorthRecruiting
  • Houston Methosidst HospitalRecruiting
  • The University of VermontRecruiting
  • Carilion Roanoke Memorial HospitalRecruiting
  • Providence Sacred Heart Medical Center & Children's HospitalRecruiting
  • West Virginia UniversityRecruiting
  • Aurora Stint Lukes Medical CenterRecruiting
  • The Alfred HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Allgemeines Krankenhaus - Universitätskliniken WienRecruiting
  • CHU de Liege- Hopital du Sart TilmanRecruiting
  • London Health Sciences Centre - University CampusRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)Recruiting
  • RigshospitaletRecruiting
  • CHRU Brest - Hôpital de la Cavale BlancheRecruiting
  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-MontpiedRecruiting
  • Hôpital de la TimoneRecruiting
  • Institut Mutualiste MontsourisRecruiting
  • Hôpital Européen Georges PompidouRecruiting
  • Universitätsklinikum BonnRecruiting
  • Herzzentrum Leipzig GmbHRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Rabin Medical Center- Beilinson HospitalRecruiting
  • Presidio Ospedaliero Gaspare RodolicoRecruiting
  • Ospedale San Raffaele - MilanoRecruiting
  • IRCCS Policlinico San DonatoRecruiting
  • Shonan Kamakura General HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Kawasaki Saiwai HospitalRecruiting
  • Osaka Police HospitalRecruiting
  • Osaka University HospitalRecruiting
  • Catharina ZiekenhuisRecruiting
  • St Antonius ZiekenhuisRecruiting
  • Hospital Universitari Clínic de BarcelonaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Complejo Asistencial Universitario de SalamancaRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting
  • Skanes UniversitetssjukhusRecruiting
  • Inselspital - Universitätsspital BernRecruiting
  • Oxford University Hospitals NHS Trust - John Radcliffe HospitalRecruiting
  • Royal Victoria Hospital - Belfast Health and Social Care TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)

Clinical site determined guideline-directed management and therapy (GDMT) alone

Arm Description

Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy

Clinical site determined guideline-directed management and therapy (GDMT) alone

Outcomes

Primary Outcome Measures

Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.

Secondary Outcome Measures

Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
Composite of all-cause mortality and heart failure hospitalizations or events.
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Heart failure hospitalizations or events.
All-cause mortality
Unplanned cardiovascular hospitalizations
Days alive and free of unplanned cardiovascular hospitalizations

Full Information

First Posted
November 24, 2021
Last Updated
October 24, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT05149755
Brief Title
Evolut™ EXPAND TAVR II Pivotal Trial
Official Title
Evolut™ EXPAND TAVR II Pivotal Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
December 2034 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS.
Detailed Description
Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis Symptomatic, Moderate Aortic Valve Stenosis
Keywords
aortic, stenosis, symptomatic, moderate, valve, TAVR

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Arm Type
Experimental
Arm Description
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
Arm Title
Clinical site determined guideline-directed management and therapy (GDMT) alone
Arm Type
No Intervention
Arm Description
Clinical site determined guideline-directed management and therapy (GDMT) alone
Intervention Type
Device
Intervention Name(s)
Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Intervention Description
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
Primary Outcome Measure Information:
Title
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
Description
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Time Frame
30 days
Title
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
Time Frame
1 year
Title
Composite of all-cause mortality and heart failure hospitalizations or events.
Time Frame
2 years
Title
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Time Frame
2 years
Title
Heart failure hospitalizations or events.
Time Frame
2 years
Title
All-cause mortality
Time Frame
2 years
Title
Unplanned cardiovascular hospitalizations
Time Frame
2 years
Title
Days alive and free of unplanned cardiovascular hospitalizations
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Moderate AS, defined as follows by transthoracic echo (TTE) at rest: AVA >1.0 cm² and < 1.5 cm² and Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, Symptoms of AS, defined as NYHA class ≥ II, or Reduced functional capacity, defined as 6MWT < 300 meters, or < 85% of age-sex predicted METs on exercise tolerance testing Any of the following HF event or hospitalization for heart failure within 1 calendar year prior to consent NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml if NT-proBNP not available), Any of the following by TTE Global longitudinal strain ≤16% (absolute value) E/e' ≥ 14.0 Diastolic dysfunction ≥ Grade II LVEF < 60% Stroke Volume Index < 35 ml/m² Paroxysmal AF or persistent AF episode within 6 months prior to consent Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) Key Exclusion Criteria: Age < 65 years LVEF ≤ 20% by 2-D echo Class I indication for cardiac surgery Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm Not anatomically suitable for transfemoral TAVR with the trial device In need of and suitable for coronary revascularization per Heart Valve Team Documented history of cardiac amyloidosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Nguyen
Phone
+1765262832
Email
hang.t.nguyen@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Nguyen
Email
rs.expandii@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Organizational Affiliation
Allina Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau, MD
Organizational Affiliation
Fondation IUCPQ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, Prof.
Organizational Affiliation
Inselspital, Universitätsspital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) 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
Mustafa Ahmed, M.D.
First Name & Middle Initial & Last Name & Degree
Dylan Addis, M.D.
Facility Name
Abrazo Arizone Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Byrne, M.D.
First Name & Middle Initial & Last Name & Degree
Merick Kirshner, 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
David Rizik, M.D.
Facility Name
Los Robles Hospital & 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
Gregory Fontana, M.D.
First Name & Middle Initial & Last Name & Degree
David Aliabadi, M.D.
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John C Messenger, M.D.
First Name & Middle Initial & Last Name & Degree
Joseph Cleveland, M.D.
Facility Name
Saint Vincents Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606-4201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lorenz, M.D.
First Name & Middle Initial & Last Name & Degree
Robert Jumper, M.D.
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Immad Sadiq
First Name & Middle Initial & Last Name & Degree
Eric Oligino, 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
Lang Lin, M.D.
First Name & Middle Initial & Last Name & Degree
Joshua Rovin, M.D.
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. David Anderson, M.D.
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, M.D.
Facility Name
Saint Vincent's Medical Center Riverside
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Garas, M.D.
First Name & Middle Initial & Last Name & Degree
Nima Taghipour, M.D
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-5054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Noel, M.D.
First Name & Middle Initial & Last Name & Degree
Gregory Hartlage, M.D.
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiriam Bezerra, M.D.
First Name & Middle Initial & Last Name & Degree
Lucian Lozonschi, M.D.
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Fail
First Name & Middle Initial & Last Name & Degree
Darrell Solet
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Resar, MD
First Name & Middle Initial & Last Name & Degree
Nisha Gilotra, 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
Marie-France Poulin, M.D.
First Name & Middle Initial & Last Name & Degree
Louis Chu, M.D.
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashequl Islam, M.D.
First Name & Middle Initial & Last Name & Degree
Anthony Rousou, M.D.
Facility Name
University of Michigan Health System - University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-1274
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
Andrew Harris, MD
Facility Name
Ascension Saint 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
Thomas Davis, M.D.
First Name & Middle Initial & Last Name & Degree
Sanjay Batra, M.D.
Facility Name
Spectrum Health
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 Mehri, M.D.
First Name & Middle Initial & Last Name & Degree
John Heiser, M.D.
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
Paul Sorajja, M.D.
First Name & Middle Initial & Last Name & Degree
Steven Bradley, 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
Sorin Pislaru, MD
First Name & Middle Initial & Last Name & Degree
Mackram Eleid, MD
Facility Name
SSM Health Saint 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
Divya Verma, MD
First Name & Middle Initial & Last Name & Degree
Steven Smart, MD
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
Fahad Gilani
First Name & Middle Initial & Last Name & Degree
Robert Capodilupo, MD
Facility Name
Northwell Health
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, M.D.
First Name & Middle Initial & Last Name & Degree
Elena Koss, M.D.
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
Tara Naib
Facility Name
Mission Hospital
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
Michael Chenier, M.D.
First Name & Middle Initial & Last Name & Degree
Mark Groh, M.D.
Facility Name
Wake Forest University Heatlh Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zhao, M.D.
First Name & Middle Initial & Last Name & Degree
Edward Kincaid, M.D.
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
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
Cristian Baeza, MD
Facility Name
Cleveland Clinic
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
Rishi Puri, M.D.
First Name & Middle Initial & Last Name & Degree
Serge Harb, M.D.
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
Scott Lillt, M.D.
First Name & Middle Initial & Last Name & Degree
Asvin Ganapathi, M.D.
Facility Name
Kettering Health Main Campus
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Schwartz, M.D.
First Name & Middle Initial & Last Name & Degree
Ammar Safar, M.D.
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
George Chrysant, M.D.
First Name & Middle Initial & Last Name & Degree
Craig Elkins, M.D.
Facility Name
Oregon Health & Science University Hospital
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
Harsh Golwala, M.D.
First Name & Middle Initial & Last Name & Degree
Scott Chadderdon, M.D.
Facility Name
Lehigh Valley Hospital, Inc
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Combs, M.D.
First Name & Middle Initial & Last Name & Degree
Daniel Makowski, M.D.
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, M.D.
First Name & Middle Initial & Last Name & Degree
Atizazul Hassan Mansoor, M.D.
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Fiorilli, M.D.
First Name & Middle Initial & Last Name & Degree
Tiffany Chen, M.D.
Facility Name
Monument Health Rapid City Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Tuma, M.D.
First Name & Middle Initial & Last Name & Degree
Rajesh Pradhan, M.D.
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Coylewright, MD
First Name & Middle Initial & Last Name & Degree
Patrick Stevens, MD
Facility Name
Baylor Jack and Jane Hamilton 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
Robert Stoler, MD
First Name & Middle Initial & Last Name & Degree
Robert Hebeler, MD
Facility Name
Medical City Dallas
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
Bruce Bowers, M.D.
First Name & Middle Initial & Last Name & Degree
Todd Dewey, M.D.
Facility Name
Texas Health Harris Methodist Hospital Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukesh Sukesh Burjonroppa, M.D.
First Name & Middle Initial & Last Name & Degree
Arun Padala, M.D.
Facility Name
Houston Methosidst 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
Neal Kleiman, MD
First Name & Middle Initial & Last Name & Degree
Michael Reardon, MD
Facility Name
The University of Vermont
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, M.D.
First Name & Middle Initial & Last Name & Degree
Peter Van Buren, M.D.
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 Forest, M.D.
First Name & Middle Initial & Last Name & Degree
John Lystash, M.D.
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
Brydan Curtis, M.D.
First Name & Middle Initial & Last Name & Degree
Kavisha Singh, 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
Ramesh Daggubati, MD
First Name & Middle Initial & Last Name & Degree
Balla Sudarshan, MD
Facility Name
Aurora Stint Lukes 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
Bajwa Tanvir, MD
First Name & Middle Initial & Last Name & Degree
Jain Renuka, MD
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Walton, M.D.
First Name & Middle Initial & Last Name & Degree
James Hare, M.D
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Walton, MD
First Name & Middle Initial & Last Name & Degree
James Hare, MD
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Yong, MBBS
First Name & Middle Initial & Last Name & Degree
James Lambert, MBBS
Facility Name
Allgemeines Krankenhaus - Universitätskliniken Wien
City
Wien
ZIP/Postal Code
1030
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hengstenberg, M.D.
First Name & Middle Initial & Last Name & Degree
Raphael Rosenhek, M.D.
Facility Name
CHU de Liege- Hopital du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizio Lancellotti, M.D.
First Name & Middle Initial & Last Name & Degree
Raluca Dulgheru, M.D.
Facility Name
London Health Sciences Centre - University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Bagur, MD
First Name & Middle Initial & Last Name & Degree
Michael Chu, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Radhakrishnan, M.D.
First Name & Middle Initial & Last Name & Degree
Idan Roifman, M.D
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Rodes-Cabau, MD
First Name & Middle Initial & Last Name & Degree
Mathieu Bernier, MD
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole de Backer, M.D.
First Name & Middle Initial & Last Name & Degree
Jacob Moeller, M.D.
Facility Name
CHRU Brest - Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Gilard, MD
First Name & Middle Initial & Last Name & Degree
Romain Didier, MD
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63 000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Combaret, M.D.
First Name & Middle Initial & Last Name & Degree
Guilleaume Clerfond, M.D.
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cuisset, M.D.
First Name & Middle Initial & Last Name & Degree
Gilbert Habib, M.D.
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Caussin, MD
First Name & Middle Initial & Last Name & Degree
Jean-Luc Monin, MD
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Karam, MD
First Name & Middle Initial & Last Name & Degree
Paul Achouh, MD
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53217
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Nickenig, MD
First Name & Middle Initial & Last Name & Degree
Sebastian Zimmer, MD
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel Wahab, MD
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Dvir, M.D.
First Name & Middle Initial & Last Name & Degree
Tal Hassin
Facility Name
Rabin Medical Center- Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Kornowski, M.D.
First Name & Middle Initial & Last Name & Degree
Yaron Shapira, M.D.
Facility Name
Presidio Ospedaliero Gaspare Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Tamburino, MD
First Name & Middle Initial & Last Name & Degree
Piera Capranzano, MD
Facility Name
Ospedale San Raffaele - Milano
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Montorfano, MD
First Name & Middle Initial & Last Name & Degree
Silvia Ajello, MD
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nedy Brambilla, M.D.
First Name & Middle Initial & Last Name & Degree
Marta Barletta, M.D.
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
State/Province
Kamakura
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
First Name & Middle Initial & Last Name & Degree
Tomoki Ochiai, MD
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohei Ohno, MD
First Name & Middle Initial & Last Name & Degree
Yasunori Cho, MD
Facility Name
Kawasaki Saiwai Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
212-0014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuya Tobaru
First Name & Middle Initial & Last Name & Degree
Shuichiro Takanashi
Facility Name
Osaka Police Hospital
City
Osaka
ZIP/Postal Code
543-0035
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiki Sawa, MD
First Name & Middle Initial & Last Name & Degree
Yoshiharu Higuchi, MD
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Miyagawa, M.D.
First Name & Middle Initial & Last Name & Degree
Yasushi Sakata, M.D.
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pim Tonino
First Name & Middle Initial & Last Name & Degree
Kayan Lam
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardus Timmers, M.D.
First Name & Middle Initial & Last Name & Degree
Martin Swaans, M.D.
Facility Name
Hospital Universitari Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ander Regueiro, M.D.
First Name & Middle Initial & Last Name & Degree
Barbara Vidal i Hagemeijer, M.D.
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Sanchez Recalde, M.D.
First Name & Middle Initial & Last Name & Degree
Jose Zamorano, M.D.
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Cruz, M.D.
First Name & Middle Initial & Last Name & Degree
Beatriz Tapia, M.D.
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Amat, M.D.
First Name & Middle Initial & Last Name & Degree
Javier Lopez Diaz, M.D.
Facility Name
Skanes Universitetssjukhus
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Gotberg, MD
First Name & Middle Initial & Last Name & Degree
Patrik Gilje, MD
Facility Name
Inselspital - Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Pilgrim, MD
First Name & Middle Initial & Last Name & Degree
Michael Schmid, MD
Facility Name
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Kharbanda, M.D.
First Name & Middle Initial & Last Name & Degree
Jim Newton, M.D.
Facility Name
Royal Victoria Hospital - Belfast Health and Social Care Trust
City
Belfast
State/Province
U.k.
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganesh Manoharan, M.D.
First Name & Middle Initial & Last Name & Degree
Reuben Jeganathan, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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