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

• ClinicalTrials.gov Identifier: NCT03242642
• Recruitment Status: Recruiting
• First Posted: August 8, 2017
• Last Update Posted: May 15, 2023
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Mitral Valve Regurgitation	Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1350 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
• Actual Study Start Date: October 23, 2017
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: October 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Primary Cohort- TMVR; Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)	Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR); mitral valve replacement; Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR); Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Experimental: Mitral Annular Calcification -TMVR; Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)	Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR); mitral valve replacement; Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR); Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Outcome Measures

Primary Outcome Measures :

1. Primary Cohort [ Time Frame: 1 year ]
   all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite
2. MAC Cohort [ Time Frame: 1 year ]
   all-cause mortality and heart failure hospitalization composite

Secondary Outcome Measures :

1. all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding [ Time Frame: 30 days or hospital discharge (whichever is later) ]
   Composite
2. Change in New York Heart Association Class [ Time Frame: 30 days ]
   change in NYHA Class
3. Quality of Life Improvement [ Time Frame: 30 days (SF-12) and 3 months (KCCQ) ]
   measured by SF-12 and KCCQ
4. Echocardiographic assessments of degree mitral valve regurgitation [ Time Frame: 1 year ]
   measured by echocardiography
5. Cardiovascular hospitalizations [ Time Frame: 1 year ]
   cardiovascular hospitalizations

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Laura O'Brien; 7635289970; rs.tmvrpivotaltrial@medtronic.com

Locations

United States, Arizona

Abrazo Heart Hospital; Recruiting

Phoenix, Arizona, United States, 85018

Principal Investigator: Timothy Byrne, MD

Principal Investigator: Merick Kirshner, MD

United States, California

Scripps Memorial Hospital; Recruiting

La Jolla, California, United States, 92037

Principal Investigator: Scott Brewster, MD

Principal Investigator: Matthew Price, MD

Kaiser Permanente Los Angeles Medical Center; Recruiting

Los Angeles, California, United States, 90027

Principal Investigator: Somjot Brar, MD

Principal Investigator: Blanding Jones, MD

Keck Hospital of the University of Southern California; Recruiting

Los Angeles, California, United States, 90033

Principal Investigator: Vaughn Starnes, MD

Principal Investigator: Ray Vern Matthews, MD

Cedars Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Saibal Kar, MD

Principal Investigator: Raj Makkar, MD

Principal Investigator: Danny Ramzy, MD

Kaiser Permanente San Francisco Medical Center; Recruiting

San Francisco, California, United States, 94118-3100

Principal Investigator: Ahmad Sheikh, MD

Principal Investigator: Andrew Rassi, MD

Stanford Hospital and Clinics; Recruiting

Stanford, California, United States, 94305

Principal Investigator: David Lee, MD

Principal Investigator: Jack Boyd, MD

United States, Connecticut

Hartford Hospital; Recruiting

Hartford, Connecticut, United States, 06102

Principal Investigator: Talhat Azemi, MD

Principal Investigator: Sabet Hashim

Principal Investigator: Robert Hagberg

Yale New Haven Hospital; Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator: John K Forrest, MD

Principal Investigator: Arnar Geirsson, MD

United States, District of Columbia

MedStar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator: Ron Waksman, MD

Principal Investigator: Christian Shults, MD

United States, Florida

JFK Medical Center; Recruiting

Atlantis, Florida, United States, 33462

Principal Investigator: Mark Rothenberg, MD

Principal Investigator: Marcos Nores, MD

Morton Plant; Recruiting

Clearwater, Florida, United States, 33756

Principal Investigator: Lang L Lin, MD

Principal Investigator: Joshua J Rovin, MD

HealthPark Medical Center; Recruiting

Fort Myers, Florida, United States, 33908

Principal Investigator: Murali Muppala, MD

Principal Investigator: Michael DeFrain, MD

North Florida Regional Medical Center; Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator: Ilie Barb, MD

Principal Investigator: Charles Klodell, MD

Baptist Medical Center Jacksonville; Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator: Ruby Satpahy

United States, Georgia

Piedmont Atlanta Hospital; Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator: Pradeep Yadav, MD

Principal Investigator: James Kauten, MD

United States, Illinois

Northwestern Memorial Hospital; Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator: Chris S Malaisrie, MD

Principal Investigator: Charles Davidson, MD

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator: Clifford Kavinsky

Principal Investigator: Antone Tatooles

United States, Iowa

Mercy Medical Center; Recruiting

Des Moines, Iowa, United States, 50314

Principal Investigator: Atul Chawla, MD

Principal Investigator: Bart Jenson, MD

United States, Kansas

The University of Kansas Hospital; Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator: Mark Wiley, MD

Principal Investigator: Emmanuel Daon, MD

United States, Maryland

University of Maryland Medical Center; Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator: Mark M Vesely, MD

Principal Investigator: Bradley Taylor, MD

The Johns Hopkins Hospital; Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator: Jon Resar, MD

Principal Investigator: James Gammie, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator: Ignacio Inglessis, MD

Principal Investigator: Serguei Melnitchouk, MD

Brigham and Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator: Pinak Bipin Shah, MD

Principal Investigator: Mark Cunningham, MD

United States, Michigan

University of Michigan Health System; Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator: Stanley Chetcuti, MD

Principal Investigator: Steven Bolling, MD

Ascension St. John Hospital; Recruiting

Detroit, Michigan, United States, 48236

Principal Investigator: Theodore Schreiber

Principal Investigator: Sanjay Batra

Spectrum Health Hospital; Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator: William Merhi, MD

Principal Investigator: Stephane Leung Wai Sang, MD

United States, Missouri

Barnes-Jewish Hospital; Recruiting

Saint Louis, Missouri, United States, 63110-1003

Principal Investigator: Alan Zajarias, MD

Principal Investigator: Puja Kachroo, MD

United States, Montana

Providence St Patrick; Recruiting

Missoula, Montana, United States, 59802-4008

Principal Investigator: Daniel Spoon

United States, New Jersey

Morristown Memorial Hospital; Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator: Philippe Genereux, MD

Principal Investigator: John Brown, MD

United States, New York

North Shore University Hospital; Recruiting

Manhasset, New York, United States, 11030

Principal Investigator: Bruce Rutkin, MD

Principal Investigator: Sheel Vatsia, MD

NYU Langone Hospital - Long Island; Recruiting

Mineola, New York, United States, 11501

Principal Investigator: Richard Schwartz, MD

Principal Investigator: Khaled Salhab, MD

NYU Langone Medical Center; Recruiting

New York, New York, United States, 10016

Principal Investigator: Matthew Williams, MD

Principal Investigator: Cezar Staniloae, MD

The Mount Sinai Hospital; Recruiting

New York, New York, United States, 10029

Principal Investigator: Samin Sharma, MD

Principal Investigator: David Adams, MD

Columbia University Medical Center/NYPH; Recruiting

New York, New York, United States, 10032

Principal Investigator: Susheel Kodali, MD

Principal Investigator: Isaac George, MD

Saint Francis Hospital; Recruiting

Roslyn, New York, United States, 11576

Principal Investigator: George Petrossian, MD

Principal Investigator: Newell Robinson, MD

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator: J. Kevin Harrison, MD

Principal Investigator: Carmelo Milano, MD

United States, Ohio

The Christ Hospital; Recruiting

Cincinnati, Ohio, United States, 45219-2906

Principal Investigator: Joseph Choo, MD

Principal Investigator: Geoffrey Answini, MD

University Hospitals Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator: Guilherme Attizzani, MD

Principal Investigator: Alan Markowitz, MD

The Ohio State University Wexner Medical Center; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Konstantinos Boudoulas, MD

Principal Investigator: Bryan Whitson, MD

OhioHealth Riverside Methodist Hospital; Recruiting

Columbus, Ohio, United States, 43214

Principal Investigator: Steven Yakubov, MD

Principal Investigator: Steven Duff, MD

United States, Oklahoma

INTEGRIS Baptist Medical Center; Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contact: Jill Fife

Principal Investigator: Jeffrey Sparling, MD

Principal Investigator: Craig Elkins, MD

United States, Oregon

Providence Saint Vincent Medical Center; Recruiting

Portland, Oregon, United States, 97225

Principal Investigator: Ethan Korngold, MD

Principal Investigator: Eric Kirker, MD

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Principal Investigator: Firas Zahr, MD

Principal Investigator: Howard Song, MD

United States, Pennsylvania

UPMC Pinnacle Harrisburg Campus; Recruiting

Harrisburg, Pennsylvania, United States, 17101

Principal Investigator: Hemal Gada, MD

Principal Investigator: Mubashir Mumtaz, MD

University of Pittsburgh Medical Center UPMC Presbyterian; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator: Ibrahim Sultan, MD

Principal Investigator: Conrad Smith, MD

Lankenau Medical Center; Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator: Scott S Goldman, MD

Principal Investigator: William W Gray, MD

Principal Investigator: Basel Ramlawi, MD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator: Ashish Shah, MD

Principal Investigator: Colin Barker, MD

Principal Investigator: Brian Lindman, MD

United States, Texas

Heart Hospital of Austin; Recruiting

Austin, Texas, United States, 78756

Principal Investigator: Juhana Karha, MD

Principal Investigator: Faraz Kerendi, MD

Baylor Jack and Jane Hamilton Heart and Vascular Hospital; Active, not recruiting

Dallas, Texas, United States, 75246

CHI Saint Luke's Health-Baylor Saint Luke's Medical Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Guilherme Silva, MD

Principal Investigator: Joseph Coselli, MD

Houston Methodist Hospital; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Neal Kleiman, MD

Principal Investigator: Michael Reardon, MD

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Richard Smalling, MD

Principal Investigator: Anthony Estrera, MD

Baylor Scott & White Health (The Heart Hospital Baylor Plano); Recruiting

Plano, Texas, United States, 75093

Principal Investigator: Molly Szerlip

Principal Investigator: Robert Smith

Methodist Hospital; Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator: Jorge Alvarez, MD

Principal Investigator: Brent New, MD

United States, Virginia

University of Virginia Medical Center; Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator: Scott Lim, MD

Principal Investigator: Leora Yarboro, MD

Inova Fairfax Hospital; Recruiting

Fairfax, Virginia, United States, 22042

Principal Investigator: Shahram Yazdani, MD

Principal Investigator: Eric Sarin, MD

Sentara Norfolk General Hospital; Recruiting

Norfolk, Virginia, United States, 23507-1904

Principal Investigator: Paul Mahoney, MD

Principal Investigator: Jospeh Newton, MD

Saint Mary's Hospital/Bon Secours; Withdrawn

Richmond, Virginia, United States, 23226

Winchester Medical Center; Active, not recruiting

Winchester, Virginia, United States, 22601

United States, Washington

The Swedish Medical Center Cherry Hill; Withdrawn

Seattle, Washington, United States, 98122

Providence Sacred Heart Medical Center & Children's Hospital; Recruiting

Spokane, Washington, United States, 99204

Principal Investigator: Philip Huber, MD

Principal Investigator: Matthew Forrester, MD

United States, Wisconsin

Aurora St. Luke's Medical Center; Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator: Tanvir Bajwa, MD

Principal Investigator: Eric Weiss, MD

Canada, British Columbia

Royal Columbian Hospital; Recruiting

New Westminster, British Columbia, Canada, V3L 3W7

Principal Investigator: Khan Razi

St. Paul's Hospital; Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Principal Investigator: Wood David

Canada, Ontario

Sunnybrook Health Sciences Centre; Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator: Andrew Czarnecki

Principal Investigator: Gideon Cohen

St. Michael's Hospital; Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator: Neil Fam

Principal Investigator: Mark Peterson

Canada, Quebec

Montreal Heart Insitute; Recruiting

Montreal, Quebec, Canada, H1T 1C8

Principal Investigator: Anita Asgar

Glen Royal Victoria; Recruiting

Montreal, Quebec, Canada, H4A 3J1

Principal Investigator: Nicolo Piazza

Denmark

Rigshospitalet; Withdrawn

Copenhagen, Denmark, 2100

Sponsors and Collaborators

Medtronic Cardiovascular

Investigators

• Study Chair: Michael Mack, MD; Baylor Scott & White Hospital
• Principal Investigator: David Adams, MD; Icahn School of Medicine at Mount Sinai
• Principal Investigator: Martin Leon, MD; New York Presbyterian Hospital/Columbia University Medical Center

More Information

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT03242642
• Other Study ID Numbers: MDT17022TMV001
• First Posted: August 8, 2017
• Last Update Posted: May 15, 2023
• Last Verified: May 2023

• 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

Keywords provided by Medtronic Cardiovascular:

Heart disease; valve disease; heart valve disease; mitral regurgitation; cardiovascular disease; mitral insufficiency

Additional relevant MeSH terms:

Mitral Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases