Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation

NCT ID: NCT05846412

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-02-20

Brief Summary

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.

Detailed 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.

Conditions

Atrial Fibrillation; Mitral Regurgitation Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rhythm Control by Catheter Ablation:

Patients randomized to rhythm control with CA will undergo CA of AF.

Group Type: EXPERIMENTAL

Catheter Ablation and M-TEER

Intervention Type: OTHER

Already included in arm descriptions.

M-TEER (Control):

Patients randomized to the M-TEER group will undergo M-TEER with the MitraClip or PASCAL device to reduce FMR severity.

Group Type: ACTIVE_COMPARATOR

Catheter Ablation and M-TEER

Intervention Type: OTHER

Already included in arm descriptions.

Interventions

Catheter Ablation and M-TEER

Already included in arm descriptions.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Karl-Heinz Kuck (MD)

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

12-2022

Identifier Type: -

Identifier Source: org_study_id