Atrial Fibrillation Recurrence After Cryoballoon Ablation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Sandeep Jain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01772030
First received: January 16, 2013
Last updated: January 11, 2016
Last verified: January 2016
  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   (Adult, Senior)
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

Locations
United States, Pennsylvania
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15213
UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
Medtronic
Investigators
Principal Investigator: Sandeep K Jain, MD University of Pittsburgh
  More Information

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: January 11, 2016
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on August 28, 2016