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

NCT ID: NCT06493591

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-08-01

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.

Detailed Description

Rationale: Invasive treatment of atrial fibrillation (AF) has a limited efficacy. A substantial group of patients keep having symptoms of AF after ablation. Autonomic modulation of AF through ablation of the ganglion plexi (GP) has been suggested as an addition to surgical AF ablation. The AFACT trial demonstrated futility of GP ablation added to thoracoscopic ablation of AF at 1 and 2 years follow-up. Long term efficacy and safety of autonomic modulation of AF is unknown.

Objective: To evaluate the efficacy and safety of GP ablation in addition to thoracoscopic PVI after 10 years of follow-up in patients with advanced AF.

Study design: This single center cohort study will re-investigate participants in the AFACT trial. The study consists of three parts. First, a national mortality database examination will be conducted to identify the participants in AFACT who died in the last 10 years. Second, a prospective clinical assessment at the outpatient clinic and third a retrospective chart review. Patients will be invited to a single visit at the outpatient clinic to sign informed consent and a subsequent clinical assessment by an investigator. Additionally, patients will be examined through a 12-lead electrocardiogram(ECG), a 24-hour holter ECG, transthoracic echo (TTE), laboratory assessment and they will be asked to complete the SF-36 quality of life (QOL) questionnaire. Furthermore, a retrospective chart review will be performed integrating data from the AFACT trial with subsequent clinical information obtained through medical chart reviews were we will focus on finding the first recurrence of AF.

Study population: The study population comprises participants from the AFACT trial, who were adults who underwent thoracoscopic ablation for advanced atrial fibrillation (AF). In the AFACT trial 240 patients were randomized to thoracoscopic ablation + GP ablation or thoracoscopic ablation.

Intervention (if applicable): N.A. Main study parameters/endpoints: 1: Freedom of AF ten years after the procedure without the use of antiarrhythmic drugs. 2: Time to first AF recurrence. 3: Type of AF recurrence, i.e. paroxysmal, persistent and permanent AF and atrial tachycardia (AT). 4: Left atrial (LA) volume and function. 5: QOL. 6: Pacemaker implants. 7: Additional ablation procedures. 8: Major adverse events.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefit of this study is that patients have an extra control visit to investigate the heart rhythm and that physical examination is performed, if necessary. This study carries no risks for the patients.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• AFACT Trial participant

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC

OTHER

Sponsor Role: lead

Responsible Party

J.R. de Groot

Principal Investigator, Professor of electrophysiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Dr. J.R. de Groot

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Central Contacts

Prof. Dr. J.R. de Groot

Role: CONTACT

j.r.degroot@amsterdamumc.nl

003120-5669111 ext. 28921

Marc Terpstra, MD

Role: CONTACT

m.m.terpstra@amsterdamumc.nl

0031205666837

Other Identifiers

NL87358.018.24

Identifier Type: -

Identifier Source: org_study_id