Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

This study has been completed.
Information provided by (Responsible Party):
Dr. med. Daniel Steven, Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: November 4, 2012
Last updated: November 8, 2012
Last verified: November 2012

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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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 identifier: NCT01724437

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 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on March 03, 2015