Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary vein isolation, Pharmacological rhythm management.
- Who it may be relevant to
- Registry conditions: Fibrillation, Atrial, Atrial Cardiomyopathy. Basic parameters: 65 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Pulmonary vein isolation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA) - Drug Pharmacological rhythm management
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation
Primary outcome measures
- A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit. [Time frame: through study completion, a median of 2.5 years]
Secondary outcome measures (8)
- ACMP progression or regression [Time frame: through study completion, a median of 2.5 years]
- Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT) [Time frame: through study completion, a median of 2.5 years]
- Hospitalisations/urgent visits for heart failure (HF) [Time frame: through study completion, a median of 2.5 years]
- Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA)) [Time frame: through study completion, a median of 2.5 years]
- Cardiovascular death [Time frame: through study completion, a median of 2.5 years]
- All-cause mortality [Time frame: through study completion, a median of 2.5 years]
- Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL) [Time frame: 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) [Time frame: through study completion, a median of 2.5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- UMCG — Groningen
Identifiers
NCT: NCT06200311 · RACE X trial