Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

Launched by UNIVERSITY HOSPITAL, GENEVA · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for patients who have persistent atrial fibrillation (a type of irregular heartbeat) and heart failure that hasn’t improved with medication. The researchers want to find out whether a procedure called atrial fibrillation ablation, which can help restore a normal heartbeat, is more effective than a combination of a pacemaker implantation and another procedure to control the heart's rhythm. The main things they will look at are how these treatments affect overall survival, hospital visits for heart issues, and heart failure-related hospital stays.

To be eligible for this trial, participants must be over 60 years old, have had at least one hospital visit for heart failure in the past two years, and have tried heart medications without success. The trial is currently recruiting participants, and it’s important to know that individuals with very severe heart failure, certain recent health events, or those involved in other clinical trials may not qualify. Participants will receive either of the two treatments and be monitored to see how well they do over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.
• • (ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval.
• • (iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years
• Exclusion Criteria:
• • (i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.
• • (ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.
• • (vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.