Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01877486
Recruitment Status : Withdrawn (funding not available)
First Posted : June 13, 2013
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jonathan S. Steinberg, University of Rochester

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.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pulmonary Vein Isolation Using Cryoablation Alone in Paroxysmal Atrial Fibrillation Patients Converted From Persistent Atrial Fibrillation With Dofetilide
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dofetilide

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




Primary Outcome Measures :
  1. Freedom from atrial fibrillation/flutter [ Time Frame: One year ]
    As assessed by one week Holters and symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for catheter ablation of AF
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877486


Locations
Layout table for location information
United States, New Jersey
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Sponsors and Collaborators
University of Rochester
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Jonathan S Steinberg, MD University of Rochester
Layout table for additonal information
Responsible Party: Jonathan S. Steinberg, Adjunct Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT01877486    
Other Study ID Numbers: UR Cryo PVI
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonathan S. Steinberg, University of Rochester:
atrial fibrillation
cryoballoon ablation
persistent AF
paroxysmal AF
dofetilide
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes