Atrial Fibrillation RecurrentREPEAT-AFNCT06199180
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF
A study testing pulmonary vein isolation with RFA and pulmonary vein isolation with PFA in people with Atrial Fibrillation Recurrent, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- pulmonary vein isolation with RFA and pulmonary vein isolation with PFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Sep 2024to 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
Subjects who meet all of the following inclusion criteria at screening will be eligible for enrolment:
- Patient had 1 previous PVI with either cryoballoon, RF ablation or PFA
- Index PVI occurred within <5 years prior to enrolment
- Documented AF recurrence >30 seconds
- Symptomatic AF
- Paroxysmal AF
- Age >18 and <80 years
- Willing and capable to provide informed consent
- Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study
Subjects who meet ANY of the following exclusion criteria will be excluded from the study:
- Persistent AF (by diagnosis of duration >7 days)
- Concomitant/ prior diagnosis for atrial tachycardia (AT) and/or atrial flutter (AFl). Note typical cavotricuspid isthmus dependent flutter is not an exclusion criterium.
- Underwent additional ablations outside the pulmonary veins during index AF ablation
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to, or unwillingness to use, systematic anticoagulation
- Left ventricular ejection fraction (LVEF) <30% as documented by transthoracic echo (TTE) (within <3 months prior)
- Left atrial volume index >60 ml/m2
- Clinically significant arrhythmias other than AF
- Previous surgery for AF
- New York Heart Association (NYHA) Functional Class III or IV
- Presence of intramural thrombus, tumour or other abnormality that precludes safe catheter introduction or manipulation
- BMI >35 kg/m2
- Significant or symptomatic hypotension, bradycardia, or chronotropic incompetence
- Chronic renal insufficiency of <15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
- Hemodynamically significant valvular disease
- Presence of patent foramen ovale (PFO) or atrial septal defect (ASD) closure device
- History of abnormal bleeding and/or clotting disorder
- History of rheumatic fever
- Severe lung disease, pulmonary hypertension, or any lung disease. Only if involving abnormal blood gases or significant dyspnoea
- Clinically significant systemic infection or sepsis
- Life expectancy <1 year
- Sensitivity to contrast media not controlled by pre-medication
- Any of the following within the 3 months prior to enrolment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart failure hospitalization
- Stroke or TIA
- Significant bleeding
- Pericarditis/effusions
- Left atrial thrombus
- Coronary artery bypass grafting/atriotomy within 6 months prior
- Organ or haematologic transplant, or currently being evaluated for an organ transplant
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, 9713GZ
Yuri Blaauw, MD, PhD, 0503616161, y.blaauw01@umcg.nl
Nick van Vreeswijk, MD, 0503616161, n.l.van.vreeswijk@umcg.nl
About this study
Official title: Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat
Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF.
PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.
Read the detailed description
All participating patients are required to provide written (or equivalent) informed consent, indicated by a dated signature of the subject or legal representative. The consent process must comply with applicable national regulations and use language understandable by the patient.
The study will be conducted at 6 clinical centres/investigational sites across the Netherlands. Patients will be randomized (1:1) into a PFA or point-by-point RF ablation arm. Randomization will occur prior to the ablation procedure. A implantable cardiac monitor will be implanted in all randomised patients one month before ablation to accurately monitor any AF/atrial flutter (AFL)/ atrial tachycardia (AT) recurrence. Treatment allocation will be processed through the Dutch 'National Heart Registry' (NHR) data platform.
Patients randomized to both arms of the study will be evaluated for PV isolation at the start of the ablation procedure. If PV reconnection is identified in patients in the point-by-point RF arm, re-ablation will occur according to the study protocol. Patients in the PFA arm will have PV reconnection determined using the FARAWAVE catheter. Those with no PV reconnection (100% PV isolation/durable PVI) will be followed in an observational registry.
The PFA ablation arm involves the use of the Farastar generator system, Farawave ablation catheter, and Faradrive steering catheter for the procedure. The RF point-by-point ablation arm (control) involves RF ablation following standard practice.
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- pulmonary vein isolation with RFA, pulmonary vein isolation with PFA
- Keywords
- pulmonary vein isolation, pulsed field ablation, radiofrequency ablation, implantable cardiac monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary vein isolation with RFADevice
Patients randomised to RFA will undergo PVI with point-by-point RFA.
pulmonary vein isolation with PFADevice
Patients randomised to PFA will undergo PVI with PFA.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Active comparator | In this group, patients will undergo the acquisition of a 3D high-density map. If pulmonary vein (PV) reconnection is identified, radiofrequency ablation (RFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry. Receives: Device: pulmonary vein isolation with RFA |
| Pulsed field ablation | Experimental | In this group, pulmonary vein (PV) reconnection is identified by the FARAWAVE system. If reconnection is observed, pulsed field ablation (PFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry. Receives: Device: pulmonary vein isolation with PFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
12-month incidence of AF/AFl/AT recurrence.
Measured: 12 months
Secondary outcomes (9)
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
24-month incidence of AF/AFl/AT recurrence.
Measured: 24 months
Repeat PVI within 12 and 24 months of randomization
Repeat PVI
Measured: 12 and 24 months
AF burden with and without 3 months blanking period
Proportion of cumulative time in AF divided by the total time accrued over follow-up
Measured: 12 and 24 months
Change in quality of life
As measured by EuroQol-5D-5L questionnaire
Measured: 12 and 24 months
Change in quality of life as affected by AF
As measured by AF Effect On Quality-Of-Life (AFEQT) questionnaire
Measured: 12 and 24 months
AF hospitalisation / urgent visit
Hospitalization/urgent visit for atrial fibrillation
Measured: 12 and 24 months
Cost-effectiveness
Cost-effectiveness
Measured: 12 and 24 months
Rate of ischemic stroke
Rate of ischemic stroke
Measured: 12 and 24 months (efficacy)
Complications of ablation
Death, stroke, pericarditis, cardiac tamponade, vascular access complications etc.
Measured: 0-30 days post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start20 Sep 2024
- Primary completionSep 2028 (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 RecurrentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomised to PFA or RFA for redo PVI
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Yuri Blaauw, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199180
- Sponsor's protocol ID
- REPEAT-AF trial
- Acronym
- REPEAT-AF
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat
- ClinicalTrials.gov ID
- NCT06199180
- Acronym / sponsor ID
- REPEAT-AF / REPEAT-AF trial
- Conditions
- Atrial Fibrillation Recurrent
- Keywords
- pulmonary vein isolation, pulsed field ablation, radiofrequency ablation, implantable cardiac monitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Jan 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.
Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF.
PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.
Detailed description
All participating patients are required to provide written (or equivalent) informed consent, indicated by a dated signature of the subject or legal representative. The consent process must comply with applicable national regulations and use language understandable by the patient.
The study will be conducted at 6 clinical centres/investigational sites across the Netherlands. Patients will be randomized (1:1) into a PFA or point-by-point RF ablation arm. Randomization will occur prior to the ablation procedure. A implantable cardiac monitor will be implanted in all randomised patients one month before ablation to accurately monitor any AF/atrial flutter (AFL)/ atrial tachycardia (AT) recurrence. Treatment allocation will be processed through the Dutch 'National Heart Registry' (NHR) data platform.
Patients randomized to both arms of the study will be evaluated for PV isolation at the start of the ablation procedure. If PV reconnection is identified in patients in the point-by-point RF arm, re-ablation will occur according to the study protocol. Patients in the PFA arm will have PV reconnection determined using the FARAWAVE catheter. Those with no PV reconnection (100% PV isolation/durable PVI) will be followed in an observational registry.
The PFA ablation arm involves the use of the Farastar generator system, Farawave ablation catheter, and Faradrive steering catheter for the procedure. The RF point-by-point ablation arm (control) involves RF ablation following standard practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patients will be randomised to PFA or RFA for redo PVI
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Active comparator | Device: pulmonary vein isolation with RFAIn this group, patients will undergo the acquisition of a 3D high-density map. If pulmonary vein (PV) reconnection is identified, radiofrequency ablation (RFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry. |
| Pulsed field ablation | Experimental | Device: pulmonary vein isolation with PFAIn this group, pulmonary vein (PV) reconnection is identified by the FARAWAVE system. If reconnection is observed, pulsed field ablation (PFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| pulmonary vein isolation with RFAPatients randomised to RFA will undergo PVI with point-by-point RFA. | Device | Radiofrequency ablation |
| pulmonary vein isolation with PFAPatients randomised to PFA will undergo PVI with PFA. | Device | Pulsed field ablation |
Primary outcome
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
Time frame: 12 months
12-month incidence of AF/AFl/AT recurrence.
9 secondary outcomes
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
Time frame: 24 months
Repeat PVI within 12 and 24 months of randomization
Time frame: 12 and 24 months
AF burden with and without 3 months blanking period
Time frame: 12 and 24 months
Change in quality of life
Time frame: 12 and 24 months
Change in quality of life as affected by AF
Time frame: 12 and 24 months
AF hospitalisation / urgent visit
Time frame: 12 and 24 months
Cost-effectiveness
Time frame: 12 and 24 months
Rate of ischemic stroke
Time frame: 12 and 24 months (efficacy)
Complications of ablation
Time frame: 0-30 days post ablation
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 10 Dec 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.
Yuri Blaauw, Dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary vein isolation with RFA and pulmonary vein isolation with PFA in people with Atrial Fibrillation Recurrent, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yuri Blaauw, Dr. (+31503616161, y.blaauw01@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation. (time frame: 12 months). 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 10 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.