Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation (CAMERA-Pilot)

University of Luebeck

Status

Not yet enrolling

Conditions

Atrial Fibrillation

Mitral Regurgitation Functional

Treatments

Other: Catheter Ablation and M-TEER

Study type

Interventional

Funder types

Other

Identifiers

NCT05846412

12-2022

Details and patient eligibility

About

The objective of the CAMERA-Pilot trial is to generate a hypothesis for a proper randomized controlled clinical endpoint trial to show the noninferiority of restoration and maintenance of sinus rhythm (via catheter ablation [CA] of AF) vs. mitral transcatheter edge-to-edge repair (M-TEER) in patients with AF and concomitant FMR. Patients will be stratified into ventricular FMR with atrial component and atrial FMR.

Full description

Rhythm Control by Catheter Ablation: Patients randomized to rhythm control with CA will undergo CA of AF. The index procedure will comprise pulmonary vein isolation (PVI) using either the cryoballoon or radiofrequency (RF) current or pulsed field ablation at the discretion of the investigator. Additional atrial substrate modification may be performed at the discretion of the investigator.

The objective of rhythm control is to restore sinus rhythm by CA and to maintain sinus rhythm during the 12-month follow-up period. In case of AF recurrence during follow-up, sinus rhythm must be restored as soon as possible, either by adding or changing AADs, electrical cardioversion, or repeat CA.

No attempt will be made to reduce FMR by interventional means. Medical treatment of FMR will follow current guidelines.

M-TEER (Control): Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity. The intervention will be considered successful if FMR is graded 2+ (moderate) or less by an echocardiography core laboratory in accordance with the 2017 Guidelines of the American Society of Echocardiography and specific guidelines on valvular regurgitation after percutaneous valve repair or replacement.

No attempt will be made to restore sinus rhythm, except for patients who remain symptomatic due to AF during follow-up. Medical treatment of AF will follow current guidelines.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic ventricular FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to cardiomyopathy of either ischemic or non-ischemic etiology (LVEF 30-49%), concomitant with AF
Symptomatic atrial FMR (moderate-to-severe [grade 3+] or severe [4+] by independent echocardiographic core laboratory assessment) due to AF, with normal (≥50%) LVEF
LV end-systolic diameter ≤70 mm
Documented history of paroxysmal AF (PAF) or persistent AF for maximally 2 years
Subject has been adequately treated medically for at least 4 weeks per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation and heart failure
NYHA functional class II, III or ambulatory IV
Local heart team has determined that MV surgery is not indicated as a treatment option or will be high risk
Age 18-80 years

Exclusion criteria

Untreated clinically significant coronary artery disease requiring revascularization
CABG, PCI or TAVR within prior 30 days
Aortic or tricuspid valve disease (tricuspid regurgitation ≥3+) requiring surgery or transcatheter intervention
Cerebrovascular accident within prior 30 days
Severe symptomatic carotid stenosis (>70% by ultrasound)
Carotid surgery or stenting within prior 30 days
NYHA functional class IV requiring in-hospital care
Implant of CRT or CRT-D within the last 30 days
Transseptal puncture anatomically not feasible
Leaflet anatomy which may preclude MitraClip/PASCAL implantation, proper MitraClip/PASCAL positioning on the leaflets, or sufficient reduction in mitral regurgitation by the MitraClip/PASCAL device.
Current pregnancy or planned pregnancy within next 12 months