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Atrial Fibrillation Ablation and Autonomic Modulation via Thoracoscopic Surgery, 10 year follow up.

Atrial Fibrillation Ablation and Autonomic Modulation via Thoracoscopic Surgery, 10 year follow up. - AFACT-10

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57228
Enrollment
236
Registered
2025-01-06
Start date
2025-11-18
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

afib Atrial fibrillation

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participant AFACT-trial, comprising of patients who had advanced AF and were randomized to thoracoscopic pulmonary vein isolation for AF with or without aditional epicardial ganglion plexus ablation.

Exclusion criteria

Exclusion criteria: Refusal to be contacted for future studies

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint: The primary endpoint of the study is freedom of AF after ten years after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of episodes of AF, atrial flutter or atrial tachycardia >30 seconds on all holters and ECG recordings during follow up.

Secondary

MeasureTime frame
Secondary study parameters/endpoints: - Classification of AF recurrence (paroxysmal, persistent, permanent AF, and atrial tachycardia). - Left Atrial (LA) Volume and Function 8 to 10 years post procedure - Difference in Quality of Life from baseline to ten years post-procedure in points - Number and reasons for pacemaker implants during the ten-year follow-up period. - Number and reasons for additional ablation procedures during the ten-year follow-up period. - Occurrence of major adverse events (heart failure, stroke, major bleeding, mortality) during the follow-up period. - Causes of death during the ten year follow-up. - Freedom of AF with AADs, defined as the absence of documentation of episodes of AF, atrial flutter or atrial tachycardia >30 seconds since start of the last dose of AAD, measured at the time of data collection 10 years safter the procedure.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)