Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation

• Registration Number: NCT05496998
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Detailed Description

Prospective, single-arm, multi-center, interventional, pre-market trial

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2023-02-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2029-08
• Study Completion: 2038-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
• Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
• Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion Criteria

• Estimated life expectancy of less than 24 months
• Currently surgically implanted mitral valve
• Prior transcatheter mitral valve procedure with device currently implanted
• Anatomic contraindications
• Anatomically prohibitive mitral annular calcification (MAC)
• Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
• LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
• Left ventricular end diastolic diameter (LVEDD) > 75mm
• Need for emergent or urgent surgery
• Hemodynamic instability
• History of bleeding diathesis or coagulopathy
• End stage renal disease
• Liver failure
• Frailty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.	30 days	Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Safety: all-cause mortality at 1-year post-procedure.	1 year	Rate of all-cause mortality at 1-year post-procedure.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).	1 year	Change of Quality of Life (QoL) at 1 year as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Rate of all-cause mortality (Safety).	30 days	Rate of all-cause mortality at 30 days post-procedure.
Disabling stroke (Safety).	30 days	Rate of disabling stroke at 30 days post-procedure.
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).	30 days	Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Major access site vascular complications (Safety).	30 days	Number of major access site vascular complications at 30 days post-procedure.
NYHA functional class (Efficacy).	1 year	Change in NYHA functional class at 1 year (Efficacy).
Reoperation or reintervention (Safety).	30 days	Rate of reoperation or reintervention at 30 days post-procedure.
Mitral valve regurgitation (Efficacy).	1 year	Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory.
Cardiovascular hospitalizations (Efficacy).	1 year	Cardiovascular hospitalizations through 1 year (Efficacy).

Trial Locations

Locations (35)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Clinique Pasteur; 🇫🇷 Toulouse, Cedex 03, France

CHU Bordeaux; 🇫🇷 Bordeaux, Pessac Cedex, France

Henri-Mondor University Hospital; 🇫🇷 Créteil, France

CHU Timone; 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU Rennes - Pontchaillou Hospital; 🇫🇷 Rennes, France

Centre Cardiologique du Nord (CCN); 🇫🇷 Saint-Denis, France

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