Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein IsolationREPEAL-AFNCT04506814
Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF
A study testing Endocardial PVI and Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI in people with Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation, run by University of Rochester at 1 site in United States.
Trial summary
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation
- What is being tested?
- Endocardial PVI and Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Jan 2028
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Symptomatic paroxysmal AF despite prior 1 or 2 PVI procedures within past 10 years (paroxysmal AF lasting up to 7 days before spontaneous termination)
- Eligible for referral for re-ablation based on current guidelines
- LA diameter < 6.0 cms on transthoracic echo
- Willingness to comply with post-procedural follow-up requirements and to sign informed consent
Who cannot join
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to anticoagulation)
- Prior history of open heart surgery
- Prior history of pericarditis or pericardiocentesis
- Prior history of stroke/TIA/systemic embolism
- NYHA class IV congestive heart failure or LVEF < 25%
- Persistent or longstanding persistent AF (duration > 1 year)
Show all 17Show fewer
- Coronary revascularization or valve surgery within 3 months
- Prior valve surgery using a mechanical prosthesis
- An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
- Life expectancy <1 year for any medical condition
- AF due to reversible cause e.g. hyperthyroid state
- Women who are pregnant or plan to become pregnant during the course of the trial** Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization.
- Participation in other clinical trials that will affect the objectives of this study
- History of non-compliance to medical therapy
- Inability or unwillingness to provide informed consent
- Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
- Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester
Short Hills, New Jersey, 07078
About this study
Official title: Comparison of Repeat Endocardial PVI Vs Epicardial Posterior Wall Isolation and LAA Clip Plus PVI for Recurrent Atrial Fibrillation After Prior PVI
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.
Read the detailed description
In these redo ablation patients, the ideal re-ablation strategy is unknown and many techniques have been proposed but there is no consensus nor strong clinical trial data.
This treatment gap prompted the development of a combined minimally invasive epicardial and endocardial ablation ("Convergent") procedure. During the last decade, this "hybrid" approach has garnered increasing acceptance in clinical practice, with several reports of promising antiarrhythmic outcomes in challenging disease states, as well as modifications to maximize safety and clinical outcomes. One key aspect of this approach is that it targets key drivers of AF including the PVs but also the left atrial posterior wall (LAPW), combining endocardial and epicardial energy delivery. The LAPW (or "PV myocardium") shares similar embryological origins and electrophysiological properties with the PVs, is predisposed to develop fibrosis, and thus recognized as an important source of AF. Recently, the CONVERGE randomized clinical trial demonstrated superiority of this hybrid approach compared to PVI in patients with persistent AF.
The left atrial appendage (LAA) has also been designated as a potential important trigger site of AF, and if isolated, may result in improved post-ablation AF outcomes. Although catheter-based isolation is controversial due to the potential to increase the risk of stroke, surgical exclusion of the LAA by placement of an occlusive clip has been suggested to be both antiarrhythmic and anti-thrombotic. Thus it is proposed in this trial to incorporate the LAA clip within the hybrid procedure.
Given the sheer volume of patients undergoing ablation of AF and the predictable necessity to perform repeat ablation procedures on a portion of these patients, the need for a proven redo ablation strategy is self-evident. The investigators thus propose a randomized clinical trial to determine if there is incremental efficacy by performing LAPW/LAA isolation via a hybrid approach in comparison to the conventional redo PVI alone in patients with paroxysmal AF.
- Being tested
- Endocardial PVI, Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial PVIDevice
Catheter based PVI
Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVIDevice
Minimally invasive PVI with posterior wall RF ablation + LAA clip + endocardial PVI
| Study group | Role | What they receive |
|---|---|---|
| Endocardial PVI | Active comparator | Endocardial complete PVI Receives: Device: Endocardial PVI |
| Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI | Experimental | Minimally invasive surgical hybrid ablation using the convergent approach plus LAA exclusion using the clip Receives: Device: Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation > 30 secs
Based on serial 7-day Holter recordings
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein IsolationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Meshalkin Research Institute of Pathology of Circulation
- Responsible party
- Principal investigator, Jonathan Steinberg, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506814
- Sponsor's protocol ID
- UR Re-ablation Paroxysmal AF
- Acronym
- REPEAL-AF
- Status last verified
- Nov 2023
- First submitted
- 4 Aug 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Repeat Endocardial PVI Vs Epicardial Posterior Wall Isolation and LAA Clip Plus PVI for Recurrent Atrial Fibrillation After Prior PVI
- ClinicalTrials.gov ID
- NCT04506814
- Acronym / sponsor ID
- REPEAL-AF / UR Re-ablation Paroxysmal AF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Meshalkin Research Institute of Pathology of Circulation
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Aug 2020 (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.
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.
Detailed description
In these redo ablation patients, the ideal re-ablation strategy is unknown and many techniques have been proposed but there is no consensus nor strong clinical trial data.
This treatment gap prompted the development of a combined minimally invasive epicardial and endocardial ablation ("Convergent") procedure. During the last decade, this "hybrid" approach has garnered increasing acceptance in clinical practice, with several reports of promising antiarrhythmic outcomes in challenging disease states, as well as modifications to maximize safety and clinical outcomes. One key aspect of this approach is that it targets key drivers of AF including the PVs but also the left atrial posterior wall (LAPW), combining endocardial and epicardial energy delivery. The LAPW (or "PV myocardium") shares similar embryological origins and electrophysiological properties with the PVs, is predisposed to develop fibrosis, and thus recognized as an important source of AF. Recently, the CONVERGE randomized clinical trial demonstrated superiority of this hybrid approach compared to PVI in patients with persistent AF.
The left atrial appendage (LAA) has also been designated as a potential important trigger site of AF, and if isolated, may result in improved post-ablation AF outcomes. Although catheter-based isolation is controversial due to the potential to increase the risk of stroke, surgical exclusion of the LAA by placement of an occlusive clip has been suggested to be both antiarrhythmic and anti-thrombotic. Thus it is proposed in this trial to incorporate the LAA clip within the hybrid procedure.
Given the sheer volume of patients undergoing ablation of AF and the predictable necessity to perform repeat ablation procedures on a portion of these patients, the need for a proven redo ablation strategy is self-evident. The investigators thus propose a randomized clinical trial to determine if there is incremental efficacy by performing LAPW/LAA isolation via a hybrid approach in comparison to the conventional redo PVI alone in patients with paroxysmal AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocardial PVI | Active comparator | Device: Endocardial PVIEndocardial complete PVI |
| Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI | Experimental | Device: Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVIMinimally invasive surgical hybrid ablation using the convergent approach plus LAA exclusion using the clip |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Symptomatic paroxysmal AF despite prior 1 or 2 PVI procedures within past 10 years (paroxysmal AF lasting up to 7 days before spontaneous termination)
- Eligible for referral for re-ablation based on current guidelines
- LA diameter < 6.0 cms on transthoracic echo
- Willingness to comply with post-procedural follow-up requirements and to sign informed consent
Key exclusion criteria (17 listed)
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to anticoagulation)
- Prior history of open heart surgery
- Prior history of pericarditis or pericardiocentesis
- Prior history of stroke/TIA/systemic embolism
- NYHA class IV congestive heart failure or LVEF < 25%
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 |
|---|---|---|
| Endocardial PVICatheter based PVI | Device | Endocardial PVI |
| Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVIMinimally invasive PVI with posterior wall RF ablation + LAA clip + endocardial PVI | Device | Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI |
Primary outcome
Atrial fibrillation > 30 secs
Time frame: At 1 year
Based on serial 7-day Holter recordings
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocardial PVI and Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI in people with Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation, run by University of Rochester at 1 site in United States.
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 5 inclusion and 17 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: withdrawn, as of the sponsor's last update on 9 Nov 2023. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation > 30 secs (time frame: At 1 year). 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 9 Nov 2023.