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Recruiting NCT03242642

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

No phase Interventional Mitral Valve Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR), Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR).
Who it may be relevant to
Registry conditions: Mitral Valve Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Primary Cohort [Time frame: 1 year]
  • MAC Cohort [Time frame: 1 year]
Secondary outcome measures (6)
  • 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)]
  • Degree of mitral regurgitation [Time frame: 6 months]
  • Quality of Life Improvement [Time frame: 3 months (KCCQ)]
  • Change in New York Heart Association Class [Time frame: 30 days]
  • Echocardiographic assessments of degree mitral valve regurgitation [Time frame: 1 year]
  • Cardiovascular hospitalizations [Time frame: 1 year]

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 <25%
  • need for emergent or urgent surgery
  • hemodynamic instability

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 78 centers
  • University of Alabama Birmingham (UAB) Hospital — Birmingham
  • Abrazo Heart Hospital — Phoenix
  • Scripps Memorial Hospital — La Jolla
  • PIH Health Good Samaritan Hospital — Los Angeles
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles
  • Keck Hospital of the University of Southern California, USC — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • El Camino Hospital — Mountain View
  • … and 70 more centers
Canada · 6 centers
  • Royal Columbian Hospital — New Westminster
  • Saint Paul's Hospital — Vancouver
  • … and 4 more centers
Denmark · 1 center

Center list to be confirmed — check the primary protocol.

Publications

  • Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. PMID 41251714

Identifiers

NCT: NCT03242642 · MDT17022TMV001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗