NCT06200311Recruiting
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Source: ClinicalTrials.gov · Last updated 18 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 604 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- 25 Jul 2024
- Primary completion date
- 25 Jul 2029
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Atrial fibrillation
- NCT number
- NCT06200311
What you commit to
- Study type: Interventional
- Planned participants: 604
- From 25 Jul 2024 to the primary completion date, 25 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial (LA) ablation or LA surgery
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 65 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.