Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMao Chen
About this trial
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Left ventricular ejection fraction ≥ 50%
Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
Valve morphology: MR originating from the mid portion of the valve; mitral valve area> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth< 11 mm, coaptation length> 2 mm
Disqualifiers
Life expectancy< 1 year due to non-cardiac conditions
Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or <severe but extending into the leaflets), and/or any mixed pathology
Active endocarditis of the mitral valve or rheumatic mitral valve disease
Hypotension (systolic pressure < 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
Trial design
Treatments tested in this trial
- Transcatheter edge to edge repair
- Catheter ablation
Treatment groups
384 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov