Atrial FibrillationAFACT-10NCT06493591
Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.
An observational study of Atrial Fibrillation, run by Amsterdam UMC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- AFACT Trial participant
Who cannot join
- Refusal to be contacted for future studies during or since the AFACT trial.
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
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.
Read the 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
- Keywords
- Atrial Fibrillation, Thoracoscopy, Ganglia, autonomic, Ganglion Plexus, Ablation
- Medical subject headings
- Atrial Fibrillation, Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (8)
Time to first AF recurrence.
Time to first AF recurrence defined as the first documentation of documentation of AF >30 seconds during follow up.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 10 years
Pacemaker implants
Number and reasons for pacemaker implants during the ten-year follow-up period.
Measured: 10 years
Additional ablation
Number and reasons for additional ablation procedures during the ten-year follow-up period.
Measured: 10 years
Cardioversions
Number and reasons for cardioversions during the ten-year follow up.
Measured: 10 years
Major cardiovascular adverse events
Occurrence of major adverse events (heart failure, stroke, major bleeding, mortality) during the follow-up period.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. de Groot, Amsterdam UMC
- Investigators
- Prof. Dr. J.R. de Groot, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493591
- Sponsor's protocol ID
- NL87358.018.24
- Acronym
- AFACT-10
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.
- ClinicalTrials.gov ID
- NCT06493591
- Acronym / sponsor ID
- AFACT-10 / NL87358.018.24
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Thoracoscopy, Ganglia, autonomic, Ganglion Plexus, Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amsterdam UMCUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- AFACT Trial participant
Key exclusion criteria (1 listed)
- Refusal to be contacted for future studies during or since the AFACT trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom of AF
Time frame: 10 years
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.
8 secondary outcomes
Time to first AF recurrence.
Time frame: Within 10 year follow up.
Classification of AF recurrence
Time frame: 10 years
Left Atrial Volume and Function
Time frame: Between 8 and 10 years follow up
Quality of Life improvement
Time frame: 10 years
Pacemaker implants
Time frame: 10 years
Additional ablation
Time frame: 10 years
Cardioversions
Time frame: 10 years
Major cardiovascular adverse events
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. J.R. de Groot principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Amsterdam UMC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. J.R. de Groot (003120-5669111 ext. 28921, j.r.degroot@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of AF (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.