NCT07744035Not yet recruiting
Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation
Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 384 (estimated)
- First submitted
- 18 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Mao Chen
- Diseases
- Atrial fibrillation
- NCT number
- NCT07744035
What you commit to
- Study type: Interventional
- Planned participants: 384
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization
- Any prior MV surgery or transcatheter procedure
Other illness
- Life expectancy\< 1 year due to non-cardiac conditions
- Active endocarditis of the mitral valve or rheumatic mitral valve disease
- Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure\> 70 mmHg
- Need for any cardiac surgery (other than for MV disease)
- Untreated clinically significant coronary artery disease
- Active infections requiring current antibiotic therapy
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits
Lab values
- Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media
Other
- 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
- Hypotension (systolic pressure \< 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Echocardiographic evidence of intracardiac thrombus
- Pregnancy
- Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment
Who the study is looking for
- 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
- Rate control in suspected AF-induced cardiomyopathy (heart rate \<80 bpm at rest and \<110 bpm during exercise)
- Patients must be willing to comply with all follow-up requirements
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.