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

NCT01877486 | Withdrawn

• 1 other identifier: UR Cryo PVI
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

atrial fibrillation; cryoballoon ablation; persistent AF; paroxysmal AF; dofetilide

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation/flutter

  As assessed by one week Holters and symptoms

  One year

Study Arms (1)

Cryoballoon ablation

After pre-treatment with dofetilide and conversion of persistent AF to sinus rhythm, performance of PVI using cryoballoon

Procedure: Ablation

Interventions

Ablation PROCEDURE

Pulmonary vein isolation following dofetilide

Cryoballoon ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for catheter ablation of AF

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Medtronic: collaborator

Study Sites (1)

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan S Steinberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor of Medicine

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: June 13, 2013
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)