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

Sponsor
Medtronic Cardiovascular (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03242642
Collaborator
(none)
1,350
Enrollment
59
Locations
2
Arms
131.3
Anticipated Duration (Months)
22.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 23, 2017
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 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 [1 year]

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

  2. MAC Cohort [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 [30 days or hospital discharge (whichever is later)]

    Composite

  2. Change in New York Heart Association Class [30 days]

    change in NYHA Class

  3. Quality of Life Improvement [30 days (SF-12) and 3 months (KCCQ)]

    measured by SF-12 and KCCQ

  4. Echocardiographic assessments of degree mitral valve regurgitation [1 year]

    measured by echocardiography

  5. Cardiovascular hospitalizations [1 year]

    cardiovascular hospitalizations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Abrazo Heart Hospital Phoenix Arizona United States 85018
2 Scripps Memorial Hospital La Jolla California United States 92037
3 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
4 Keck Hospital of the University of Southern California Los Angeles California United States 90033
5 Cedars Sinai Medical Center Los Angeles California United States 90048
6 Kaiser Permanente San Francisco Medical Center San Francisco California United States 94118-3100
7 Stanford Hospital and Clinics Stanford California United States 94305
8 Hartford Hospital Hartford Connecticut United States 06102
9 Yale New Haven Hospital New Haven Connecticut United States 06510
10 MedStar Washington Hospital Center Washington District of Columbia United States 20010
11 JFK Medical Center Atlantis Florida United States 33462
12 Morton Plant Clearwater Florida United States 33756
13 HealthPark Medical Center Fort Myers Florida United States 33908
14 North Florida Regional Medical Center Gainesville Florida United States 32605
15 Piedmont Atlanta Hospital Atlanta Georgia United States 30309
16 Northwestern Memorial Hospital Chicago Illinois United States 60611
17 Mercy Medical Center Des Moines Iowa United States 50314
18 The University of Kansas Hospital Kansas City Kansas United States 66160
19 University of Maryland Medical Center Baltimore Maryland United States 21201
20 The Johns Hopkins Hospital Baltimore Maryland United States 21287
21 Massachusetts General Hospital Boston Massachusetts United States 02114
22 Brigham and Women's Hospital Boston Massachusetts United States 02115
23 University of Michigan Health System Ann Arbor Michigan United States 48109
24 Spectrum Health Hospital Grand Rapids Michigan United States 49503
25 Barnes-Jewish Hospital Saint Louis Missouri United States 63110-1003
26 Morristown Memorial Hospital Morristown New Jersey United States 07960
27 North Shore University Hospital Manhasset New York United States 11030
28 NYU Winthrop Hospital Mineola New York United States 11501
29 NYU Langone Medical Center New York New York United States 10016
30 The Mount Sinai Hospital New York New York United States 10029
31 Columbia University Medical Center/NYPH New York New York United States 10032
32 Saint Francis Hospital Roslyn New York United States 11576
33 Duke University Medical Center Durham North Carolina United States 27710
34 The Christ Hospital Cincinnati Ohio United States 45219-2906
35 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
36 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
37 OhioHealth Riverside Methodist Hospital Columbus Ohio United States 43214
38 INTEGRIS Baptist Medical Center Oklahoma City Oklahoma United States 73112
39 Providence Saint Vincent Medical Center Portland Oregon United States 97225
40 Oregon Health and Science University Portland Oregon United States 97239
41 UPMC Pinnacle Harrisburg Campus Harrisburg Pennsylvania United States 17101
42 University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
43 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
44 Vanderbilt University Medical Center Nashville Tennessee United States 37203
45 Heart Hospital of Austin Austin Texas United States 78756
46 Baylor Jack and Jane Hamilton Heart and Vascular Hospital Dallas Texas United States 75246
47 CHI Saint Luke's Health-Baylor Saint Luke's Medical Center Houston Texas United States 77030
48 Houston Methodist Hospital Houston Texas United States 77030
49 The University of Texas Health Science Center at Houston Houston Texas United States 77030
50 Methodist Hospital San Antonio Texas United States 78229
51 University of Virginia Medical Center Charlottesville Virginia United States 22908
52 Inova Fairfax Hospital Fairfax Virginia United States 22042
53 Sentara Norfolk General Hospital Norfolk Virginia United States 23507-1904
54 Saint Mary's Hospital/Bon Secours Richmond Virginia United States 23226
55 Winchester Medical Center Winchester Virginia United States 22601
56 The Swedish Medical Center Cherry Hill Seattle Washington United States 98122
57 Providence Sacred Heart Medical Center & Children's Hospital Spokane Washington United States 99204
58 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
59 Rigshospitalet 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT03242642
Other Study ID Numbers:
  • MDT17022TMV001
First Posted:
Aug 8, 2017
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
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

Study Results

No Results Posted as of Aug 8, 2022