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Atrial Fibrillation Recurrence After Cryoballoon Ablation

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772030
First Posted: January 21, 2013
Last Update Posted: May 11, 2017
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.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Sandeep Jain, University of Pittsburgh
  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: None (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 Sandeep Jain, University of Pittsburgh:

Primary Outcome Measures:
  • Presence or absence of pulmonary vein isolation or reconnection [ Time Frame: During repeat cryoballoon ablation procedure ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: January 16, 2013
First Posted: January 21, 2013
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Sandeep Jain, University of Pittsburgh:
Atrial Fibrillation
Cryoballoon Ablation

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