Heart procedure versus medicines for irregular heartbeat in older adults with enlarged atria
Compares ablation with medicines to control atrial fibrillation in people with enlarged heart atria.
Plain-language title generated from the registry record
Registry title: Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Key facts
- Where
- Groningen, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 65 and 80 years old?
Source: NCT06200311, who can take part
Where in Netherlands
- UMCGGroningen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT06200311
- Record updated
- 18 October 2024
- Original description
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.Read full original descriptionShow less
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
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.
Inclusion: 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: Previous left atrial (LA) ablation or LA surgery; 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)); Presence of (or scheduled for) mechanical assist device or heart transplant; Severe aortic or mitral valve disease; Complex congenital heart disease; Longstanding (>1 year) persistent or permanent (accepted) AF; AF due to a reversible cause (e.g. hyperthyroidism, post-operative AF); Intracardiac thrombus; HF NYHA III/IV; Impaired renal function, defined as estimated glomerular filtration rate ≤25 ml/min/1.73m2; Life expectancy <1 year; Currently enrolled in another clinical randomized trial.