Atrial Flutter TypicalPREVENT-AF IINCT07649603
Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation
A study testing Catheter ablation in people with Atrial Flutter Typical, run by University of Rochester.
Trial summary
Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Atrial Flutter Typical
- What is being tested?
- Catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to May 2032
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years on date of consent
- History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year
- No identifiable AF on any prior ECG within past 1 year
- CHA2DS2 -VASc ≥ 2
Who cannot join
- Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus)
- AFL or AF due to reversible cause e.g. hyperthyroid state
- Contraindication to systemic anticoagulation
- Prior surgical or percutaneous cardiac ablation procedure any time in the past
- Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past
- LV ejection fraction < 35%
Show all 20Show fewer
- Paroxysmal, persistent or longstanding persistent AF
- Presence of NYHA Class IV congestive heart failure
- Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
- Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
- Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
- Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
- Any medical condition likely to limit survival to < 1 year
- Renal failure requiring dialysis at time of consent
- Pregnancy
- History of non-compliance to medical therapy
- Participation in other clinical trials (observational/lead registries are allowed) without approval from the DCC
- 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
About this study
Official title: Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation: The PREVENT-AF Study II
Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in atrial flutter (AFL) patients.
This is a multicenter single-blind randomized controlled trial, "Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation" (PREVENT AF II) to determine if PVI in conjunction with AFL ablation for patients with typical AFL results in a significant reduction in cardiac events and healthcare utilization.
Read the detailed description
Atrial flutter (AFL) is a distinct arrhythmic entity with a recognizable ECG phenotype resulting from a well characterized atrial arrhythmia mechanism. Typical AFL results from a single reentrant circuit located in the right atrium. The circuit is large and entirely confined to the right atrium, revolving around the tricuspid annulus. The reentrant circuit rotates in a counterclockwise direction, caudocranial along the interatrial septum and craniocaudal along the right atrial free wall. An area of slow conduction exists in the posterior-inferior aspect of the circuit, with a fully excitable gap. It is believed that most circuits utilize an anatomic or functional obstacle in the posterior right atrium, such as the crista terminalis and inferior vena cava.
AFL is diagnosed in about 200,000 new cases per year in the US. Because of the high- risk of recurrence of typical AFL with medical therapy, catheter ablation of the cavo-tricuspid isthmus has emerged as definitive and first-line treatment for these patients. The AFL ablation procedure is performed in about 47,000 patients per year in the US. However, it has been recognized that in many of these patients, atrial fibrillation (AF) will develop during follow-up.
PVI via catheter ablation has been successfully employed for years to treat symptomatic AF. Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in AFL patients. Based on this pilot trial, we propose a multicenter randomized clinical trial enrolling 620 patients with paroxysmal or persistent typical AFL (with no known AF) who have been referred for a catheter ablation procedure based on conventional clinical indications and who will be randomized 1:1 to catheter ablation of the cavo-tricuspid isthmus (CTI) for AFL alone (control group) or catheter ablation of AFL plus complete PVI (experimental group ) with prespecified clinical endpoints. There is a strong premise based on several observational studies and a few small pilot trials that prophylactic PVI in patients undergoing AFL ablation for AFL is associated with a significant reduction in the risk and burden of AF in comparison to AFL ablation performed without concomitant PVI. However, data from these clinical trials are lacking in regard to whether PVI in addition to routine AFL ablation will contribute to a significant reduction in cardiac events and healthcare utilization.
- Conditions
- Atrial Flutter Typical
- Being tested
- Catheter ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationDevice
CTI ablation; pulmonary vein isolation (PVI)
| Study group | Role | What they receive |
|---|---|---|
| Atrial flutter ablation | Active comparator | Radiofrequency or pulsed field catheter ablation from the tricuspid annulus to the inferior vena cava in the cavo-tricuspid isthmus Receives: Device: Catheter ablation |
| Atrial flutter ablation + prophylactic pulmonary vein isolation | Experimental | After completion of the standard atrial flutter ablation, radiofrequency, cryoballoon or pulsed field ablation of the pulmonary veins Receives: Device: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
Time to cardiovascular hospitalization/emergency room visits, stroke, or death, whichever comes first
Measured: Up to 4 years
Secondary outcomes (3)
Quality of life before and after ablation
Atrial Fibrillation Effect Severity Scale (AFSS) consisting of 19 items including a visual analogue scale related to global well-being; 4 items on AF frequency, duration and severity (AF Burden); 4 items on health care utilization; and most importantly, 7 items regarding the severity of specific symptoms (AF Symptom Score). Scores range between 0 to 35, and higher scores mean worse quality of life.
Measured: 12 months and baseline
Procedural complications
Adverse events
Measured: 1 month
Number of subjects with Incident atrial fibrillation
Obtained by standard of care ECGs or ECG recordings
Measured: During follow-up of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2027 (estimated)
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Flutter TypicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to study and control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Steinberg, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649603
- Sponsor's protocol ID
- 2114335
- Acronym
- PREVENT-AF II
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Steinberg JS, Romanov A, Musat D, Preminger M, Bayramova S, Artyomenko S, Shabanov V, Losik D, Karaskov A, Shaw RE, Pokushalov E. Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: the PReVENT AF Study I. Heart Rhythm. 2014 Sep;11(9):1567-72. doi: 10.1016/j.hrthm.2014.05.011. Epub 2014 May 12.
PubMed 24832767
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation: The PREVENT-AF Study II
- ClinicalTrials.gov ID
- NCT07649603
- Acronym / sponsor ID
- PREVENT-AF II / 2114335
- Conditions
- Atrial Flutter Typical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 16 Jun 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.
Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in atrial flutter (AFL) patients.
This is a multicenter single-blind randomized controlled trial, "Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation" (PREVENT AF II) to determine if PVI in conjunction with AFL ablation for patients with typical AFL results in a significant reduction in cardiac events and healthcare utilization.
Detailed description
Atrial flutter (AFL) is a distinct arrhythmic entity with a recognizable ECG phenotype resulting from a well characterized atrial arrhythmia mechanism. Typical AFL results from a single reentrant circuit located in the right atrium. The circuit is large and entirely confined to the right atrium, revolving around the tricuspid annulus. The reentrant circuit rotates in a counterclockwise direction, caudocranial along the interatrial septum and craniocaudal along the right atrial free wall. An area of slow conduction exists in the posterior-inferior aspect of the circuit, with a fully excitable gap. It is believed that most circuits utilize an anatomic or functional obstacle in the posterior right atrium, such as the crista terminalis and inferior vena cava.
AFL is diagnosed in about 200,000 new cases per year in the US. Because of the high- risk of recurrence of typical AFL with medical therapy, catheter ablation of the cavo-tricuspid isthmus has emerged as definitive and first-line treatment for these patients. The AFL ablation procedure is performed in about 47,000 patients per year in the US. However, it has been recognized that in many of these patients, atrial fibrillation (AF) will develop during follow-up.
PVI via catheter ablation has been successfully employed for years to treat symptomatic AF. Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in AFL patients. Based on this pilot trial, we propose a multicenter randomized clinical trial enrolling 620 patients with paroxysmal or persistent typical AFL (with no known AF) who have been referred for a catheter ablation procedure based on conventional clinical indications and who will be randomized 1:1 to catheter ablation of the cavo-tricuspid isthmus (CTI) for AFL alone (control group) or catheter ablation of AFL plus complete PVI (experimental group ) with prespecified clinical endpoints. There is a strong premise based on several observational studies and a few small pilot trials that prophylactic PVI in patients undergoing AFL ablation for AFL is associated with a significant reduction in the risk and burden of AF in comparison to AFL ablation performed without concomitant PVI. However, data from these clinical trials are lacking in regard to whether PVI in addition to routine AFL ablation will contribute to a significant reduction in cardiac events and healthcare utilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized 1:1 to study and control groups
| Arm | Type | Receives |
|---|---|---|
| Atrial flutter ablation | Active comparator | Device: Catheter ablationRadiofrequency or pulsed field catheter ablation from the tricuspid annulus to the inferior vena cava in the cavo-tricuspid isthmus |
| Atrial flutter ablation + prophylactic pulmonary vein isolation | Experimental | Device: Catheter ablationAfter completion of the standard atrial flutter ablation, radiofrequency, cryoballoon or pulsed field ablation of the pulmonary veins |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 55 years on date of consent
- History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year
- No identifiable AF on any prior ECG within past 1 year
- CHA2DS2 -VASc ≥ 2
Key exclusion criteria (20 listed)
- Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus)
- AFL or AF due to reversible cause e.g. hyperthyroid state
- Contraindication to systemic anticoagulation
- Prior surgical or percutaneous cardiac ablation procedure any time in the past
- Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past
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 |
|---|---|---|
| Catheter ablationCTI ablation; pulmonary vein isolation (PVI) | Device | Atrial flutter ablation, Atrial flutter ablation + prophylactic pulmonary vein isolation |
Primary outcome
Composite endpoint
Time frame: Up to 4 years
Time to cardiovascular hospitalization/emergency room visits, stroke, or death, whichever comes first
3 secondary outcomes
Quality of life before and after ablation
Time frame: 12 months and baseline
Procedural complications
Time frame: 1 month
Number of subjects with Incident atrial fibrillation
Time frame: During follow-up of 24 months
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 2 Oct 2026.
- Results publication: PubMed 24832767Steinberg JS, Romanov A, Musat D, Preminger M, Bayramova S, Artyomenko S, Shabanov V, Losik D, Karaskov A, Shaw RE, Pokushalov E. Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: the PReVENT AF Study I. Heart Rhythm. 2014 Sep;11(9):1567-72. doi: 10.1016/j.hrthm.2014.05.011. Epub 2014 May 12.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation in people with Atrial Flutter Typical, run by University of Rochester.
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 20 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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?
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?
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?
Composite endpoint (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07649603, which also lists 1 linked publication.
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 2 Oct 2026.