Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.

NCT06493591 | Not Yet Recruiting

• 1 other identifier: NL87358.018.24
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study investigates the long-term outcomes of patients ten years after their participation in a previous study on the surgical treatment of atrial fibrillation (AF). Participants were part of a the AFACT study a decade ago that explored whether damaging nerves around the heart could reduce AF. Participants were randomized to standard thoracoscopic AF ablation (MiniMaze) with or without Ganglion Plexus (GP) ablation. This new study aims to assess and compare the long-term effects of these treatments. We are specifically interested which treatment leads to more freedom from AF. Key questions include: How many patients are free from AF ten years after treatment without using antiarrhythmic drugs? What are the complications from both treatments? Participants will undergo the following assessments:

• Clinical assessment at the outpatient clinic.
• ECG and 24-hour Holter ECG
• Echocarddiogram and laboratory assessment.
• SF-36 Quality of life questionnaire.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Thoracoscopy; Ganglia, autonomic; Ganglion Plexus; Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom of AF

  Number of participants with 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.

  10 years

Secondary Outcomes (8)

• Time to first AF recurrence.

  Within 10 year follow up.

• Classification of AF recurrence

  10 years

• Left Atrial Volume and Function

  Between 8 and 10 years follow up

• Quality of Life improvement

  10 years

• Pacemaker implants

  10 years

Study Arms (2)

Subgroup: GP ablation

Participants underwent thoracoscopic AF ablation with additional GP ablation as the intervention group in the AFACT study. PVI with additional left atrial ablation lines was performed and conduction block was verified. No additional intervention will be perforemd in this study. All study procedures will be the same for the two subgroups.

Subgroup: No GP ablation

Participants underwent thoracoscopic AF ablation as the control group in the AFACT study. PVI with additional left atrial ablation lines was performed and conduction block was verified. No additional intervention will be perforemd in this study. All study procedures will be the same for the two subgroups.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises participants from the AFACT trial, all of whom underwent thoracoscopic ablation for advanced AF. The AFACT trial encompassed 240 patients that underwent thoracosopic AF ablation for persistent AF, enlarged left atria (left atrial volume index \[LAVI\] \>33 ml/m2), prior unsuccessful catheter ablation, or patient preference for thoracoscopic ablation. Patients had a mean age at time of inclusion of 59.9 +-8.2 years and 73% of participants were male. Importantly, the surgical ablation occurred approximately 10 years ago for for all participants. During the AFACT trial, 4 out of the 240 patients died, leaving a maximum of 236 patients for this analysis.

You may qualify if:

• AFACT Trial participant

You may not qualify if:

• Refusal to be contacted for future studies during or since the AFACT trial.

Sponsors & Collaborators

• Amsterdam UMC: lead

MeSH Terms

Conditions

Atrial Fibrillation; Ganglion Cysts

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Prof. Dr. J.R. de Groot

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. J.R. de Groot

CONTACT

003120-5669111; j.r.degroot@amsterdamumc.nl

Marc Terpstra, MD

CONTACT

0031205666837; m.m.terpstra@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of electrophysiology

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07