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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
  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
Atrial Fibrillation Tachycardia Procedure: pulmonary vein isolation Procedure: pulmonary vein isolation with additional ablation of fragmented potentials

Study Type: Interventional
Study Design: 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

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 ]

Enrollment: 124
Study Start Date: May 2008
Study Completion Date: February 2017
Primary Completion Date: February 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Sponsors and Collaborators
Asklepios proresearch
Investigators
Principal Investigator: Karl-Heinz Kuck, PhD, MD Asklepios Klinik St. Georg, Department of Cardiology
  More Information

Responsible Party: Asklepios proresearch
ClinicalTrials.gov Identifier: NCT00820625     History of Changes
Other Study ID Numbers: 1787
PV 2961 ( Other Identifier: Ethical Board Hamburg )
First Submitted: January 9, 2009
First Posted: January 12, 2009
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:
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes