The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Asklepios proresearch.
Recruitment status was:  Recruiting
Information provided by:
Asklepios proresearch Identifier:
First received: January 9, 2009
Last updated: June 21, 2011
Last verified: June 2011
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.

Condition Intervention Phase
Atrial Fibrillation
Procedure: pulmonary vein isolation
Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials

Resource links provided by NLM:

Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:
  • data collection in view of acute and chronic success rate [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • data collection of complications in both groups and also procedure parameters [ Time Frame: 12 months ]

Estimated Enrollment: 108
Study Start Date: May 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ablation: pulmonary vein isolation
Procedure: pulmonary vein isolation
common pulmonary vein isolation procedure
Active Comparator: 2
ablation: pulmonary vein isolation with additional ablation of fragmented potentials
Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
common pulmonary vein isolation with additional but also common ablation of fragmented potentials


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • long standing persistent atrial fibrillation > 6 months and < 5 years

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm
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Please refer to this study by its identifier: NCT00820625

Asklepios Klinik St. Georg
Hamburg, Germany
Sponsors and Collaborators
Asklepios proresearch
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. med. Asklepios Klinik St. Georg, Department of Cardiology
  More Information

Responsible Party: Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Department of Cardiology Identifier: NCT00820625     History of Changes
Other Study ID Numbers: 1787  PV 2961 
Study First Received: January 9, 2009
Last Updated: June 21, 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on January 19, 2017