Alster-Lost-AF-Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Asklepios proresearch.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT00820625
First received: January 9, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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
Tachycardia
Procedure: pulmonary vein isolation
Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • data collection of complications in both groups and also procedure parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820625

Contacts
Contact: Karl-Heinz Kuck, Prof. Dr. med. +49401818852305 k.kuck@asklepios.com

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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 14, 2014