Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Daniel Steven, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01724437
First received: November 4, 2012
Last updated: November 8, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • time to AF recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    recurrence of AF as assessed by 3 day holter monitoring

  • time to AT recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    assessment of AT recurrence using 3 day holter monitoring


Secondary Outcome Measures:
  • procedure duration [ Time Frame: completed (15 months) ] [ Designated as safety issue: No ]
    time needed to complete the procedure

  • procedure safety [ Time Frame: up to three days after the procedure ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724437

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

No publications provided

Responsible Party: Dr. med. Daniel Steven, Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01724437     History of Changes
Other Study ID Numbers: PV3503
Study First Received: November 4, 2012
Last Updated: November 8, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014