Atrial Cardiomyopathy, Fibrillation, Atrial
Conditions
Keywords
pulmonary vein isolation, mHealth, atrial fibrillation, atrial cardiomyopathy, AF ablation
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.
Interventions
PROCEDUREPulmonary vein isolation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)
DRUGPharmacological rhythm management
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
endpoints will be adjudicated by a blinded clinical endpoint committee
Intervention model description
Eligible patients with ACMP and AF will be randomised to AF ablation and pharmacological rhythm management
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| ACMP progression or regression | through study completion, a median of 2.5 years | As measured by LAVI (left atrial volume index) increase or decrease |
| 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 | — |
| Cardiovascular death | through study completion, a median of 2.5 years | Cardiovascular death |
Countries
Netherlands
Contacts
Primary ContactMichiel Rienstra, Prof. dr.
Backup ContactNick L van Vreeswijk, Drs.
Outcome results
None listed