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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014