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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

January 9, 2009
June 21, 2011
May 2008
August 2011   (final data collection date for primary outcome measure)
data collection in view of acute and chronic success rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00820625 on ClinicalTrials.gov Archive Site
data collection of complications in both groups and also procedure parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Alster-Lost-AF-Study
Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Tachycardia
  • Procedure: pulmonary vein isolation
    common pulmonary vein isolation procedure
  • Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
    common pulmonary vein isolation with additional but also common ablation of fragmented potentials
  • Active Comparator: 1
    ablation: pulmonary vein isolation
    Intervention: Procedure: pulmonary vein isolation
  • Active Comparator: 2
    ablation: pulmonary vein isolation with additional ablation of fragmented potentials
    Intervention: Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
August 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm
Both
18 Years to 75 Years
No
Contact: Karl-Heinz Kuck, Prof. Dr. med. +49401818852305 k.kuck@asklepios.com
Germany
 
NCT00820625
1787, PV 2961
No
Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Department of Cardiology
Asklepios proresearch
Not Provided
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. med. Asklepios Klinik St. Georg, Department of Cardiology
Asklepios proresearch
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP