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

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ClinicalTrials.gov Identifier: NCT00820625
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Asklepios proresearch

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Tachycardia Procedure: pulmonary vein isolation Procedure: pulmonary vein isolation with additional ablation of fragmented potentials Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : May 2008
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820625


Locations
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Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Sponsors and Collaborators
Asklepios proresearch
Investigators
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Principal Investigator: Karl-Heinz Kuck, PhD, MD Asklepios Klinik St. Georg, Department of Cardiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asklepios proresearch
ClinicalTrials.gov Identifier: NCT00820625    
Other Study ID Numbers: 1787
PV 2961 ( Other Identifier: Ethical Board Hamburg )
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease