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Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation (Alster-Lost)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00820625
First Posted: January 12, 2009
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asklepios proresearch
January 9, 2009
January 12, 2009
February 8, 2017
May 2008
February 2017   (Final data collection date for primary outcome measure)
data collection in view of acute and chronic success rate [ Time Frame: 12 months ]
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 ]
Same as current
Not Provided
Not Provided
 
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
 
Completed
124
February 2017
February 2017   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00820625
1787
PV 2961 ( Other Identifier: Ethical Board Hamburg )
No
Not Provided
Plan to Share IPD: Undecided
Asklepios proresearch
Asklepios proresearch
Not Provided
Principal Investigator: Karl-Heinz Kuck, PhD, MD Asklepios Klinik St. Georg, Department of Cardiology
Asklepios proresearch
February 2017

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