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Clinical Trials in the Netherlands / NCT06200311
Recruiting Not applicable

Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

NCT06200311 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Not applicable
Started
2024-07-25
Last updated
2024-10-18

Condition(s) studied

Fibrillation, AtrialAtrial Cardiomyopathy

Investigational drug(s) / intervention(s)

Pulmonary vein isolationPharmacological rhythm management

Pulmonary vein isolation: Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)

Pharmacological rhythm management: 1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
UMCG Groningen Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06200311 on ClinicalTrials.gov ↗ ← All trials in the Netherlands