Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation

NCT05846412 | Not Yet Recruiting DMC

• 1 other identifier: 12-2022
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Mitral Regurgitation Functional

Outcome Measures

Primary Outcomes (1)

• FMR grade ≤2+ (moderate or less) at 1 year

  The FMR grade will be assessed with transesophageal echocardiography

  24 Month

Study Arms (2)

Rhythm Control by Catheter Ablation:

EXPERIMENTAL

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

Other: Catheter Ablation and M-TEER

M-TEER (Control):

ACTIVE COMPARATOR

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

Other: Catheter Ablation and M-TEER

Interventions

Catheter Ablation and M-TEER OTHER

Already included in arm descriptions.

M-TEER (Control):; Rhythm Control by Catheter Ablation:

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 20, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-04