RecruitingNot ApplicableNCT06200311

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


Sponsor

University Medical Center Groningen

Enrollment

604 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether ablation (a procedure that uses heat or energy to destroy the tissue triggering irregular heartbeats) for atrial fibrillation (AFib) can slow the progression of a related heart condition called atrial cardiomyopathy — where the upper chambers of the heart become enlarged and weakened. **You may be eligible if...** - You are 65–80 years old - You have confirmed atrial cardiomyopathy (enlarged left atrium) and ECG-confirmed AFib - Your AFib has not been present continuously for more than 1 year - You have not had previous ablation or surgery on the left atrium - Your doctor considers you a candidate for ablation **You may NOT be eligible if...** - Your AFib has been permanent or persistent for over 1 year - You have had a prior left atrium ablation or surgery - Your AFib is caused by a treatable condition like thyroid disease - You had a heart attack or acute coronary syndrome within the past 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

UMCG

Groningen, Netherlands

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NCT06200311


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