Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation

NCT07649603 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2114335
• Study Type: interventional
• Target: 620
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Atrial Flutter Typical

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  Time to cardiovascular hospitalization/emergency room visits, stroke, or death, whichever comes first

  Up to 4 years

Secondary Outcomes (4)

• Quality of life before and after ablation

  12 months and baseline

• Procedural complications

  1 month

• Number of subjects with Incident atrial fibrillation

  At 6, 12 and 24 months

• Atrial Fibrillation Severity Scale (AFSS) (Scored 0-35, with higher scores worse quality of life)

  12 months and baseline

Study Arms (2)

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

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

Device: Catheter ablation

Interventions

Catheter ablation DEVICE

CTI ablation; pulmonary vein isolation (PVI)

Atrial flutter ablation; Atrial flutter ablation + prophylactic pulmonary vein isolation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Left atrial diameter ≥ 4.5 cm within 12 calendar months prior to or on consent date by transthoracic echocardiography
• No identifiable AF on any prior ECG within past 1 year
• CHA2DS2 -VASc ≥ 2

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• University of Rochester: lead

Related Publications (1)

• 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.

  PMID: 24832767 RESULT

MeSH Terms

Interventions

Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor- Department of Medicine, Cardiology Heart Research (SMD)

Model Details: Randomized 1:1 to study and control groups

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2032
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share