Alster-Lost-AF-Study - Full Text View

Sponsored by:	Asklepios proresearch
Information provided by:	Asklepios proresearch
ClinicalTrials.gov Identifier:	NCT00820625

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 IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ablation: pulmonary vein isolation	Procedure: pulmonary vein isolation common pulmonary vein isolation procedure
2: Active Comparator 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

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

Responsible Party:	Asklepios Klinik St. Georg, Department of Cardiology ( Prof. Dr. med. Karl-Heinz Kuck )
Study ID Numbers:	1787, PV 2961
Study First Received:	January 9, 2009
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00820625
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 06, 2009