The APOLLO Trial: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
open
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility
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