Atrial Fibrillation Recurrence After Cryoballoon Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Sandeep Jain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01772030
First received: January 16, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.


Condition Intervention
Atrial Fibrillation
Other: Use of the Achieve catheter followed by ICE-guided mapping catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Mechanisms and Patterns of Atrial Fibrillation Recurrence After Cryoballoon Ablation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Presence or absence of pulmonary vein isolation or reconnection [ Time Frame: During repeat cryoballoon ablation procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Recurrent Atrial Fibrillation Other: Use of the Achieve catheter followed by ICE-guided mapping catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
  • At least 18 years old
  • Able to read and understand informed consent

Exclusion Criteria:

  • Unable to give informed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772030

Contacts
Contact: Mary Jo Rose, RN, BSN 412-864-0788 Rosemj@upmc.edu
Contact: Lynn Billisits, RN, BSN 412-648-6024 Billisitsl@upmc.edu

Locations
United States, Pennsylvania
UPMC Passavant Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Mary Jo Rose, RN, BSN    412-864-0788    Rosemj@upmc.edu   
Contact: Lynn Billisits, RN, BSN    412-648-6024    Billisitsl@upmc.edu   
Principal Investigator: Sandeep K Jain, MD         
Sub-Investigator: William Barrington, MD         
Sub-Investigator: Raveen Bazaz, MD         
Sub-Investigator: Samir Saba, MD         
Sub-Investigator: David Schwartzman, MD         
Sub-Investigator: Jan Nemec, MD         
Sub-Investigator: Evan Adelstein, MD         
Sub-Investigator: Andrew Voigt, MD         
Sub-Investigator: G. Stuart Mendenhall, MD         
Sub-Investigator: Norman Wang, MD         
UPMC Presbyterian Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mary Jo Rose, RN, BSN    412-748-0788    Rosemj@upmc.edu   
Contact: Lynn Billisits, RN BSN    412-648-6024    Billisitsl@upmc.edu   
Principal Investigator: Sandeep K Jain, MD         
Sub-Investigator: William Barrington, MD         
Sub-Investigator: Raveen Bazaz, MD         
Sub-Investigator: Samir Saba, MD         
Sub-Investigator: David Schwartzman, MD         
Sub-Investigator: Jan Nemec, MD         
Sub-Investigator: Evan Adelstein, MD         
Sub-Investigator: Andrew Voigt, MD         
Sub-Investigator: G. Stuart Mendenhall, MD         
Sub-Investigator: Norman Wang, MD         
Sponsors and Collaborators
University of Pittsburgh
Medtronic
Investigators
Principal Investigator: Sandeep K Jain, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Sandeep Jain, Associate Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01772030     History of Changes
Other Study ID Numbers: PRO12060524
Study First Received: January 16, 2013
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Atrial Fibrillation
Cryoballoon Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014