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Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724437
First Posted: November 9, 2012
Last Update Posted: November 12, 2012
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.
Information provided by (Responsible Party):
Dr. med. Daniel Steven, Universitätsklinikum Hamburg-Eppendorf
  Purpose
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Condition Intervention
Paroxysmal Atrial Fibrillation Catheter Ablation Strategies Device: catheter based pulmonary vein isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dr. med. Daniel Steven, Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • time to AF recurrence [ Time Frame: 12 months ]
    recurrence of AF as assessed by 3 day holter monitoring

  • time to AT recurrence [ Time Frame: 12 months ]
    assessment of AT recurrence using 3 day holter monitoring


Secondary Outcome Measures:
  • procedure duration [ Time Frame: completed (15 months) ]
    time needed to complete the procedure

  • procedure safety [ Time Frame: up to three days after the procedure ]
    complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed


Enrollment: 102
Study Start Date: November 2009
Study Completion Date: November 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Loss of pace capture
Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved
Device: catheter based pulmonary vein isolation
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
Active Comparator: Conventional
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.
Device: catheter based pulmonary vein isolation
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written informed consent
  • age > 18 years
  • paroxysmal atrial fibrillation

Exclusion Criteria:

  • structural heart disease
  • intracardiac thrombus
  • reversible causes of atrial fibrillation
  • inability to take warfarin
  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): NCT01724437


Locations
Germany
University Hospital Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Daniel Steven, Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01724437     History of Changes
Other Study ID Numbers: PV3503
First Submitted: November 4, 2012
First Posted: November 9, 2012
Last Update Posted: November 12, 2012
Last Verified: November 2012

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