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

ConditionsFibrillation, AtrialAtrial Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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))

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary vein isolation

    Procedure/Surgery

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

  • Pharmacological rhythm management

    Drug

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

Treatment groups

604 Participants
are divided into 2 treatment groups
Group A: AF ablationExperimental treatment 1 intervention
Group B: Pharmacological rhythm managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.

Atrial cardiomyopathy (ACMP)-associated complications

Time frame
through study completion, a median of 2.5 years

Secondary outcomes

1

ACMP progression or regression

As measured by LAVI (left atrial volume index) increase or decrease

Time frame
through study completion, a median of 2.5 years
2

Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)

Hospitalisations/urgent visits for AF, AFL or AT

Time frame
through study completion, a median of 2.5 years
3

Hospitalisations/urgent visits for heart failure (HF)

Hospitalisations/urgent visits for heart failure

Time frame
through study completion, a median of 2.5 years
4

Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))

Hospitalisations/urgent visits for ischemic stroke (including TIA)

Time frame
through study completion, a median of 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Source ClinicalTrials.gov
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