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Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation

ConditionAtrial Flutter Typical
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Catheter ablation

    Device

    CTI ablation; pulmonary vein isolation (PVI)

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Atrial flutter ablationActive comparator 1 intervention
Group B: Atrial flutter ablation + prophylactic pulmonary vein isolationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite endpoint

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

Time frame
Up to 4 years

Secondary outcomes

1

Quality of life before and after ablation

Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) (Score 0-100, higher scores indicate better quality of life

Time frame
12 months and baseline
2

Procedural complications

Adverse events

Time frame
1 month
3

Number of subjects with Incident atrial fibrillation

Obtained by serial 7-day Holters and standard of care ECGs

Time frame
At 6, 12 and 24 months
4

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

Quality of life questionnaire

Time frame
12 months and baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: