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
Recruitment status was Recruiting
Sponsor:
Asklepios proresearch
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT00820625
First received: January 9, 2009
Last updated: June 21, 2011
Last verified: June 2011
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
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
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 Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2015