Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

NCT ID: NCT06200311

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2029-07-25

Brief Summary

The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index >34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.

Detailed Description

The RACE X trial investigates the impact of atrial cardiomyopathy (ACMP) and ablation timing on adverse outcomes in atrial fibrillation (AF) patients. ACMP leads to an atrial substrate less responsive to rhythm control, exacerbating AF recurrence and progression. This trial assesses whether AF ablation versus pharmacological rhythm management reduces the combined primary endpoint of cardiovascular (CV) death and hospitalization in ACMP and AF patients. Secondary objectives include measuring ACMP progression, ACMP-related outcomes, mortality, hospitalizations, AF symptoms, quality of life, and healthcare costs. Exploratory goals involve various additional measurements. This prospective, multicenter, open-label, blinded-endpoint, phase IIIb trial randomizes patients with ACMP and AF to receive either AF ablation or pharmacological rhythm management. Follow-up involves mobile health (mHealth) applications, questionnaires, and heart rhythm monitoring across 13 Dutch hospitals. Ineligible patients undergoing AF ablation join an observational registry. The trial population consists of patients aged 65-80 years with confirmed ACMP and ECG-confirmed AF. With 604 patients and a median 2.5-year follow-up, the trial aims to assign patients equally to each intervention. The primary endpoint is a composite of CV death and hospitalization. Catheter ablation, a safe and efficient technique, minimizes patient burden, and remote follow-up through mHealth reduces site visits. Additional study procedures are integrated into routine care, ensuring a streamlined process.

Conditions

Fibrillation, Atrial; Atrial Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AF ablation

These patients will undergo Pulmonary vein isolation (PVI) (only)

Group Type: EXPERIMENTAL

Pulmonary vein isolation

Intervention Type: PROCEDURE

Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)

Pharmacological rhythm management

These patients will take rate control medication. If this therapy fails, pharmacological rhythm control and AF ablation are 2nd and 3rd line options respectively within this arm,

Group Type: ACTIVE_COMPARATOR

Pharmacological rhythm management

Intervention Type: DRUG

1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation

Interventions

Pulmonary vein isolation

Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)

Intervention Type: PROCEDURE

Pharmacological rhythm management

1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation

Intervention Type: DRUG

Other Intervention Names

AF ablation

Eligibility Criteria

Inclusion Criteria

• Confirmed ACMP (LAVI >34 ml/m2)
• ECG-confirmed AF
• Age: 65-80 years old
• Patients eligible for both treatment strategies judged by the treating physician signed and dated informed consent prior to admission to the trial

Exclusion Criteria

• Longstanding (>1 year) persistent or permanent (accepted) AF
• Previous left atrial (LA) ablation or LA surgery
• AF due to a reversible cause (e.g. hyperthyroidism, post-operative AF)
• Recent (<90 days) acute coronary syndrome, stroke/TIA or cardiac intervention (Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical))
• Intracardiac thrombus
• HF NYHA III/IV
• Impaired renal function, defined as estimated glomerular filtration rate ≤25 ml/min/1.73m2
• Presence of (or scheduled for) mechanical assist device or heart transplant
• Severe aortic or mitral valve disease
• Complex congenital heart disease
• Life expectancy <1 year
• Currently enrolled in another clinical randomized trial

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michiel Rienstra, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

UMCG

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Michiel Rienstra, Prof. dr.

Role: CONTACT

m.rienstra@umcg.nl

+31503616161

Nick L van Vreeswijk, Drs.

Role: CONTACT

nickvanvreeswijk@gmail.com

0624678451

Other Identifiers

RACE X trial

Identifier Type: -

Identifier Source: org_study_id