Persistent Atrial FibrillationPVI-PLUSNCT07405359
PVI Alone Versus PVI Plus PWI and SVCI With PFA
A study testing AF Ablation: PVI + PWI + SVCI, PFA and Implantable loop recorder in people with Persistent Atrial Fibrillation, run by Edward Gerstenfeld, MD at 1 site in United States.
Trial summary
Catheter based ablation of atrial fibrillation (AF) is an established treatment modality for rhythm control of AF, with pulmonary vein isolation (PVI) being the cornerstone of this technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- AF Ablation: PVI + PWI + SVCI, PFA and Implantable loop recorder
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2026to 14 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at their pre-procedure visit
- Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs>7 days apart or ≥3 cardioversions
- Indicated and interested in ICM implant for monitoring post ablation
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Who cannot join
- Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
- Stroke or transient ischemic attack within the previous six months
- Gastrointestinal bleeding within the previous three months
- Implanted pacemaker or defibrillator
- Longstanding persistent AF (> 3 years)
- LA volume >80ml/m2
Show all 19Show fewer
- Atrial septal occlusion device
- Current left atrial thrombus
- Left atrial appendage occlusion or closure device < 6 mos or with leak or prior DRT
- Mitral or Tricuspid valve clip or mechanical replacement or clip
- Hypertrophic cardiomyopathy
- Contraindication to femoral vascular access
- Congenital heart disease with residual anatomic abnormality
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Pregnancy
- Left ventricular ejection fraction <30%
- Baseline creatinine >2.0 mg/dL
- Predicted life expectancy less than one year
- Refusal to receive ICM implant or allergy to ICM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Randomized Trial of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation Plus Posterior Wall and Superior Vena Cava Isolation With Pulsed Field Ablation for Treatment of Persistent Atrial Fibrillation
Catheter based ablation of atrial fibrillation (AF) is an established treatment modality for rhythm control of AF, with pulmonary vein isolation (PVI) being the cornerstone of this technique. While pulmonary vein triggers are the predominant arrhythmia mechanism in paroxysmal AF, development of additional atrial substrate contributes to maintenance of AF in persistent AF. This is likely to account for the lower rates of freedom from recurrent AF following ablation in patients with persistent AF. Various adjunctive empiric ablation strategies, such as left atrial posterior wall isolation (PWI), superior vena cava isolation (SVCI), linear ablation, and ablation of complex fractionated atrial electrograms have been studied to address this limitation of PVI alone.
While observational data supports the safety and feasibility of Posterior Wall Isolation (PWI) and Superior Vena Cava Isolation (SVCI) with PFA, the efficacy of these strategies with PFA has not been demonstrated in randomized controlled trials. Whether mapping prior to ablation (i.e. detecting scar) predicts if PW and SVC sites are effective in improving ablation outcome is unknown.
This study will test the hypothesis of whether empiric addition of PW and SVC isolation with PFA to PVI improves outcome (freedom from atrial tachyarrhythmia at 1-year). The investigators therefore propose a randomized controlled trial to compare the efficacy of Pulmonary Vein Isolation (PVI) alone versus PVI + PWI + SVCI in patients with persistent AF. The investigators hypothesize that the addition of PWI and SVCI to PVI in patients with persistent AF will provide improved freedom from AFIB off anti-arrhythmic drugs, without significantly increasing rates of procedural complications. Secondary analysis includes subgroups with posterior wall scar, procedure times, freedom from AFIB on or off anti arrhythmic drugs, etc.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- AF Ablation: PVI + PWI + SVCI, PFA, Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF Ablation: PVI + PWI + SVCIProcedure or surgery
Patients randomized to the 'PVI only' arm will be receiving an Afib ablation using PFA targeting the pulmonary veins for isolation (PVI). Following PVI, in those patients randomized to PVI+, PFA will also be used to isolate the left atrial posterior wall, and the superior vena cava.
PFADevice
PFA is FDA-approved for PVI and PWI. SVCI using PFA will be done for investigational purposes.
Implantable loop recorderProcedure or surgery
Implantation of implantable loop recorder during ablation procedure for continuous heart monitoring during follow up.
| Study group | Role | What they receive |
|---|---|---|
| PVI alone | Active comparator | Afib ablation: PVI only Receives: Device: PFA; Procedure: Implantable loop recorder |
| PVI + PWI + SVCI | Experimental | Afib ablation: PVI + PWI + SVCI Receives: Procedure: AF Ablation: PVI + PWI + SVCI; Device: PFA; Procedure: Implantable loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF freedom
First recurrence of AT/AFL/AF > 1 hour after a 2-month blanking period Any 1) cardioversion 2) redo ablation or 3) escalation/change in AAD after the 2-month blanking period (allowing 3 months to stop AADs) is considered a failure of the primary endpoint
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start3 Apr 2026
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Gerstenfeld, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Gerstenfeld, MD, University of California, San Francisco
- Investigators
- Edward Gerstenfeld, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405359
- Sponsor's protocol ID
- 25-44799
- Acronym
- PVI-PLUS
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation Plus Posterior Wall and Superior Vena Cava Isolation With Pulsed Field Ablation for Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07405359
- Acronym / sponsor ID
- PVI-PLUS / 25-44799
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Edward Gerstenfeld, MDUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 12 Feb 2026 (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.
Catheter based ablation of atrial fibrillation (AF) is an established treatment modality for rhythm control of AF, with pulmonary vein isolation (PVI) being the cornerstone of this technique. While pulmonary vein triggers are the predominant arrhythmia mechanism in paroxysmal AF, development of additional atrial substrate contributes to maintenance of AF in persistent AF. This is likely to account for the lower rates of freedom from recurrent AF following ablation in patients with persistent AF. Various adjunctive empiric ablation strategies, such as left atrial posterior wall isolation (PWI), superior vena cava isolation (SVCI), linear ablation, and ablation of complex fractionated atrial electrograms have been studied to address this limitation of PVI alone.
While observational data supports the safety and feasibility of Posterior Wall Isolation (PWI) and Superior Vena Cava Isolation (SVCI) with PFA, the efficacy of these strategies with PFA has not been demonstrated in randomized controlled trials. Whether mapping prior to ablation (i.e. detecting scar) predicts if PW and SVC sites are effective in improving ablation outcome is unknown.
This study will test the hypothesis of whether empiric addition of PW and SVC isolation with PFA to PVI improves outcome (freedom from atrial tachyarrhythmia at 1-year). The investigators therefore propose a randomized controlled trial to compare the efficacy of Pulmonary Vein Isolation (PVI) alone versus PVI + PWI + SVCI in patients with persistent AF. The investigators hypothesize that the addition of PWI and SVCI to PVI in patients with persistent AF will provide improved freedom from AFIB off anti-arrhythmic drugs, without significantly increasing rates of procedural complications. Secondary analysis includes subgroups with posterior wall scar, procedure times, freedom from AFIB on or off anti arrhythmic drugs, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI alone | Active comparator | Device: PFA, Procedure: Implantable loop recorderAfib ablation: PVI only |
| PVI + PWI + SVCI | Experimental | Procedure: AF Ablation: PVI + PWI + SVCI, Device: PFA, Procedure: Implantable loop recorderAfib ablation: PVI + PWI + SVCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years at their pre-procedure visit
- Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs>7 days apart or ≥3 cardioversions
- Indicated and interested in ICM implant for monitoring post ablation
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Key exclusion criteria (19 listed)
- Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
- Stroke or transient ischemic attack within the previous six months
- Gastrointestinal bleeding within the previous three months
- Implanted pacemaker or defibrillator
- Longstanding persistent AF (> 3 years)
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 |
|---|---|---|
| AF Ablation: PVI + PWI + SVCIPatients randomized to the 'PVI only' arm will be receiving an Afib ablation using PFA targeting the pulmonary veins for isolation (PVI). Following PVI, in those patients randomized to PVI+, PFA will also be used to isolate the left atrial posterior wall, and the superior vena cava. | Procedure or surgery | PVI + PWI + SVCI |
| PFAPFA is FDA-approved for PVI and PWI. SVCI using PFA will be done for investigational purposes. | Device | PVI + PWI + SVCI, PVI alone |
| Implantable loop recorderImplantation of implantable loop recorder during ablation procedure for continuous heart monitoring during follow up. | Procedure or surgery | PVI + PWI + SVCI, PVI alone |
Primary outcome
AF freedom
Time frame: 12 months
First recurrence of AT/AFL/AF > 1 hour after a 2-month blanking period Any 1) cardioversion 2) redo ablation or 3) escalation/change in AAD after the 2-month blanking period (allowing 3 months to stop AADs) is considered a failure of the primary endpoint
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 14 Jul 2026.
- 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.
Edward Gerstenfeld, MD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF Ablation: PVI + PWI + SVCI, PFA and Implantable loop recorder in people with Persistent Atrial Fibrillation, run by Edward Gerstenfeld, MD 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 4 inclusion and 19 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 14 Jul 2026. 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?
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 Marialena Varympopioti, MS (415-514-7310, mariaeleni.varympopioti@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF freedom (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 14 Jul 2026.