An observational study in Atrial Fibrillation, sponsored by Amsterdam UMC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Amsterdam UMC · Observational
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:
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
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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.
Exclusion Criteria:
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.
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.
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.
Time frame: 10 years
Time to first AF recurrence.
Time to first AF recurrence defined as the first documentation of documentation of AF \>30 seconds during follow up.
Time frame: Within 10 year follow up.
Classification of AF recurrence
Classifications of AF recurrence and change from baseline of AF recurrence classification (paroxysmal, persistent, permanent AF, and atrial tachycardia).
Time frame: 10 years
Left Atrial Volume and Function
left Atrial (LA) Volume and Function 8 to 10 years post procedure compared between the two arms. And the change in Left Atrial (LA) Volume and Function from baseline to 8 to 10 years post procedure compared.
Time frame: Between 8 and 10 years follow up
Quality of Life improvement
Improvement from baseline of functional status as measured by the RAND 36 quality of life questionnaires at 10 years
Time frame: 10 years
Pacemaker implants
Number and reasons for pacemaker implants during the ten-year follow-up period.
Time frame: 10 years
Additional ablation
Number and reasons for additional ablation procedures during the ten-year follow-up period.
Time frame: 10 years
Cardioversions
Number and reasons for cardioversions during the ten-year follow up.
Time frame: 10 years
Major cardiovascular adverse events
Occurrence of major adverse events (heart failure, stroke, major bleeding, mortality) during the follow-up period.
Time frame: 10 years
No study locations are listed for this record.
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Amsterdam UMC