Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
- Conditions
- Fibrillation, AtrialAtrial Cardiomyopathy
- Interventions
- Procedure: Pulmonary vein isolationDrug: Pharmacological rhythm management
- Registration Number
- NCT06200311
- Lead Sponsor
- University Medical Center Groningen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 604
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AF ablation Pulmonary vein isolation These patients will undergo Pulmonary vein isolation (PVI) (only) Pharmacological rhythm management 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,
- Primary Outcome Measures
Name Time Method A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit. through study completion, a median of 2.5 years Atrial cardiomyopathy (ACMP)-associated complications
- Secondary Outcome Measures
Name Time Method ACMP progression or regression through study completion, a median of 2.5 years As measured by LAVI (left atrial volume index) increase or decrease
Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT) through study completion, a median of 2.5 years Hospitalisations/urgent visits for AF, AFL or AT
Hospitalisations/urgent visits for heart failure (HF) through study completion, a median of 2.5 years Hospitalisations/urgent visits for heart failure
Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA)) through study completion, a median of 2.5 years Hospitalisations/urgent visits for ischemic stroke (including TIA)
Cardiovascular death through study completion, a median of 2.5 years Cardiovascular death
All-cause mortality through study completion, a median of 2.5 years All-cause mortality
Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL) through study completion, a median of 2.5 years Symptoms and improve quality of life (QoL) measured by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire (higher score indicating less symptoms and a better QoL) through study completion, a median of 2.5 years
Trial Locations
- Locations (1)
UMCG
🇳🇱Groningen, Netherlands