Atrial Fibrillation Recurrence After Cryoballoon Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 9, 2013
Last verified: December 2013

January 16, 2013
December 9, 2013
January 2013
January 2018   (final data collection date for primary outcome measure)
Presence or absence of pulmonary vein isolation or reconnection [ Time Frame: During repeat cryoballoon ablation procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01772030 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Atrial Fibrillation Recurrence After Cryoballoon Ablation
Mechanisms and Patterns of Atrial Fibrillation Recurrence After Cryoballoon Ablation

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.

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Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Atrial Fibrillation
Other: Use of the Achieve catheter followed by ICE-guided mapping catheter
Recurrent Atrial Fibrillation
Intervention: Other: Use of the Achieve catheter followed by ICE-guided mapping catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2019
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dina Poole, RN 412-647-2931 Pooledr@upmc.edu
Contact: Lynn Billisits, RN, BSN 412-648-6024 Billisitsl@upmc.edu
United States
 
NCT01772030
PRO12060524
No
Sandeep Jain, University of Pittsburgh
University of Pittsburgh
Medtronic
Principal Investigator: Sandeep K Jain, MD University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP