Atrial Fibrillation, PersistentAPPROACH AFNCT04715425
Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
A study testing Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation and Catheter pulmonary vein isolation without additional lesions in people with Atrial Fibrillation, Persistent, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial summary
Rationale: Atrial fibrillation (AF) is a highly prevalent cardiac arrhythmia. AF is classified as paroxysmal or persistent AF, based on the duration and persistency of the arrhythmia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation and Catheter pulmonary vein isolation without additional lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesNetherlands
- Study dates
- 25 Sep 2019to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is between 18 and 80 years
- Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
- AF documented by ECG or Holter < 1 year ago.
- At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
- Left atrial volume index ≤ 45 ml/m2
- Legally competent and willing to sign the informed consent.
- Willing and able to adhere to the follow-up visit protocol.
- Life expectancy of at least 2 years.
Who cannot join
- Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
- AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
- Documentation of CTI dependent atrial flutter
- Valvular AF
- Paroxysmal AF
- Long standing Persistent AF, defined as AF continuously present for longer than 1 year.
Show all 22Show fewer
- Body mass index >35kg/m2
- NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%.
- NYHA class III heart failure symptoms, unless caused or aggravated by AF.
- Myocardial infarction within the preceding 2 months.
- Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C).
- Known and documented carotid stenosis > 80%
- Planned cardiac surgery for other purposes than AF.
- Pregnancy or child bearing potential without adequate anticonception.
- Requirement of anti-arrhythmic drugs for ventricular arrhythmias.
- Presence of intracardiac mass or thrombus (discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the subject from the study)
- Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator).
- History of previous radiation therapy on the thorax
- Circumstances that prevent follow-up
- No vascular access for catheterization.
- History of previous thoracotomy.
- Factors precluding transseptal puncture for catheterization.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center location AMC
Amsterdam
- Not yet recruiting
Maastricht UMC+
Maastricht
- Recruiting
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein
About this study
Rationale: Atrial fibrillation (AF) is a highly prevalent cardiac arrhythmia. AF is classified as paroxysmal or persistent AF, based on the duration and persistency of the arrhythmia. Despite state-of-the-art pharmacological therapies targeting the ventricular rate or aiming to restore sinus rhythm, many patients with persistent AF stay symptomatic. Catheter ablation, endocardial pulmonary vein isolation (PVI) in particular, is the most commonly applied approach to treat drug refractory persistent AF, but particularly in this patient group results are modest. Alternatively, the PVs can be approached epicardially by thoracoscopic surgery to isolate the PVs. This approach is more efficacious, at the cost of a more invasive procedure and longer hospital stay. However, no studies have been conducted comparing catheter with thoracoscopic ablation in patients with persistent AF as a primary invasive procedure after failing treatment with anti-arrhythmic medication.
Objective: This current study aims to assess a patient specific therapy plan for patients with persistent AF by randomizing thoracoscopic versus catheter ablation for PVI without adjuvant substrate ablation in those patients.
Read more
Study design: This is a prospective, non-blinded randomized multicenter study. Subjects will be randomized (1:1) to one of the two study-arms (thoracoscopic surgical or catheter PVI). The follow-up will last 5 years, with heart rhythm monitoring at three and six months, one year and yearly in the following years. In case AF recurs during the first year, the subject will receive the treatment of the otherother arm, or according to patient choice or clinical routine.
Study population: Patients with an indication for invasive treatment of persistent AF.
Intervention: Thoracoscopic surgical or catheter PVI without additional lesions.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation, Catheter pulmonary vein isolation without additional lesions
- Keywords
- Catheter ablation, Thoracoscopic ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputationProcedure or surgery
Bilateral pulmonary vein isolation using radiofrequency energy
Catheter pulmonary vein isolation without additional lesionsProcedure or surgery
Bilateral pulmonary vein isolation using radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic ablation | Active comparator | Thoracoscopic ablation Receives: Procedure: Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation |
| Catheter ablation | Active comparator | Catheter ablation Receives: Procedure: Catheter pulmonary vein isolation without additional lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF, defined as absence of any atrial tachyarrhythmia
The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached. This is an event based endpoint. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study.
Measured: Up until 72 patients experienced AF recurrence
Secondary outcomes (5)
One year freedom of AF
Freedom of arrhythmia with or without AAD after a single procedure after one year
Measured: 1 year of follow-up
Freedom of AF after two procedures
Freedom of arrhythmia after 12 months with or without AAD after both procedures
Measured: 1 year of follow-up after the second procedure
Long term freedom of AF
Freedom of arrhythmia after 5 years
Measured: 5 years of follow-up
Cost-effectiveness
calculation of cost-effectiveness of both procedures in isolation, and the combination of both procedures.
Measured: 1 year of follow-up
Quality of life after a thoracoscopic surgical procedure or a catheter ablation procedure.
Quality of life score of all patients, in both groups. We use the general (EQ5D) and AF specific (AFEQT) quality of life outcome questionaires.
Measured: Yearly until 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start25 Sep 2019
- Primary completionSep 2024 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715425
- Sponsor's protocol ID
- NL63978.018.18
- Acronym
- APPROACH AF
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Surgical Versus Catheter Ablation Approaches for Primary Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04715425
- Acronym / sponsor ID
- APPROACH AF / NL63978.018.18
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- Catheter ablation, Thoracoscopic ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Jan 2021 (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.
Rationale: Atrial fibrillation (AF) is a highly prevalent cardiac arrhythmia. AF is classified as paroxysmal or persistent AF, based on the duration and persistency of the arrhythmia. Despite state-of-the-art pharmacological therapies targeting the ventricular rate or aiming to restore sinus rhythm, many patients with persistent AF stay symptomatic. Catheter ablation, endocardial pulmonary vein isolation (PVI) in particular, is the most commonly applied approach to treat drug refractory persistent AF, but particularly in this patient group results are modest. Alternatively, the PVs can be approached epicardially by thoracoscopic surgery to isolate the PVs. This approach is more efficacious, at the cost of a more invasive procedure and longer hospital stay. However, no studies have been conducted comparing catheter with thoracoscopic ablation in patients with persistent AF as a primary invasive procedure after failing treatment with anti-arrhythmic medication.
Objective: This current study aims to assess a patient specific therapy plan for patients with persistent AF by randomizing thoracoscopic versus catheter ablation for PVI without adjuvant substrate ablation in those patients.
Study design: This is a prospective, non-blinded randomized multicenter study. Subjects will be randomized (1:1) to one of the two study-arms (thoracoscopic surgical or catheter PVI). The follow-up will last 5 years, with heart rhythm monitoring at three and six months, one year and yearly in the following years. In case AF recurs during the first year, the subject will receive the treatment of the otherother arm, or according to patient choice or clinical routine.
Study population: Patients with an indication for invasive treatment of persistent AF.
Intervention: Thoracoscopic surgical or catheter PVI without additional lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic ablation | Active comparator | Procedure: Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputationThoracoscopic ablation |
| Catheter ablation | Active comparator | Procedure: Catheter pulmonary vein isolation without additional lesionsCatheter ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is between 18 and 80 years
- Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
- AF documented by ECG or Holter < 1 year ago.
- At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
- Left atrial volume index ≤ 45 ml/m2
Key exclusion criteria (22 listed)
- Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
- AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
- Documentation of CTI dependent atrial flutter
- Valvular AF
- Paroxysmal AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputationBilateral pulmonary vein isolation using radiofrequency energy | Procedure or surgery | Thoracoscopic ablation |
| Catheter pulmonary vein isolation without additional lesionsBilateral pulmonary vein isolation using radiofrequency energy | Procedure or surgery | Catheter ablation |
Primary outcome
Freedom of AF, defined as absence of any atrial tachyarrhythmia
Time frame: Up until 72 patients experienced AF recurrence
The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached. This is an event based endpoint. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study.
5 secondary outcomes
One year freedom of AF
Time frame: 1 year of follow-up
Freedom of AF after two procedures
Time frame: 1 year of follow-up after the second procedure
Long term freedom of AF
Time frame: 5 years of follow-up
Cost-effectiveness
Time frame: 1 year of follow-up
Quality of life after a thoracoscopic surgical procedure or a catheter ablation procedure.
Time frame: Yearly until 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation and Catheter pulmonary vein isolation without additional lesions in people with Atrial Fibrillation, Persistent, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
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 8 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J.R. de Groot, MD PhD (0205699111, EP-research@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, defined as absence of any atrial tachyarrhythmia (time frame: Up until 72 patients experienced AF recurrence). 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 25 Jan 2024.