Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-02
Brief Title:
Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery 10 Year Follow up
Sponsor:
Amsterdam UMC
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery 10 Year Follow up
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFACT-10
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
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 electrocardiogramECG 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 NA Main study parametersendpoints 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 ie 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
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 electrocardiogramECG 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 NA Main study parametersendpoints 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None