PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide (ABLATE)

Pulmonary Vein Isolation Using Cryoablation Alone in Paroxysmal Atrial Fibrillation Patients Converted From Persistent Atrial Fibrillation With Dofetilide

To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation.

Study Overview

• Status: Withdrawn
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Ablation

Detailed Description

Pulmonary vein isolation is now considered a cornerstone of all atrial fibrillation (AF) ablation procedures. In patients with paroxysmal AF, pulmonary vein isolation alone is usually sufficient. The cryoballoon is now FDA approved to achieve PVI in patients with paroxysmal AF.

Although no ablation system is yet approved in patients with persistent AF, these patients are increasingly undergoing ablation. Many investigators feel that these patients have more atrial disease and thus PVI alone is insufficient in these patients. As a result, it is common for these patients to undergo additional ablation, which is often quite extensive and exposes patients to proarrhythmia. Commonly utilized strategies include linear lesions (left atrial roof; mitral isthmus line), ablation of complex fractionated atrial electrograms (CFAEs), left atrial appendage isolation and/or even right atrial ablation. For years, the investigators have been concerned about the adverse effects of this additional ablation. The investigators postulated that the "answer" is not more ablation but trying to "reverse remodel" patients with persistent AF back to a paroxysmal form, whereby PVI alone would again be justified and sufficient. The efficacy of such a strategy has previously been demonstrated.

In brief, the investigators start patients with persistent AF on dofetilide 3 months prior to scheduled ablation. In 96% of patients, AF either suppresses completely or is transformed into a paroxysmal pattern. The net effect is "reverse remodeling" of the left atria. The investigators have confirmed this by using a reduction in P wave duration as a surrogate of remodeling. At the ablation procedure, the investigators perform PVI alone.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for catheter ablation of AF

Description

Inclusion Criteria:

• Aged 18 to 80 years
• Able and willing to give written informed consent
• Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
• Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide

Exclusion Criteria:

• Previous ablation for AF
• Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
• Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
• Presence of severe valvular disease with the need for surgical correction
• AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
• Pregnant women or women of child bearing potential and not on reliable methods of birth control
• Second or third degree AV block, sinus pause > 3 seconds, resting heart rate< 30 bpm without permanent pacemaker
• History of drug-induced Torsades de Pointes or congenital long QT syndrome
• Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryoballoon ablation; After pre-treatment with dofetilide and conversion of persistent AF to sinus rhythm, performance of PVI using cryoballoon	Procedure: Ablation; Pulmonary vein isolation following dofetilide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial fibrillation/flutter	As assessed by one week Holters and symptoms	One year

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 26, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 2, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: atrial fibrillation; paroxysmal AF; persistent AF; cryoballoon ablation; dofetilide
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: UR Cryo PVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO