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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Asklepios proresearch

ClinicalTrials.gov Identifier:

NCT00820625

First received: January 9, 2009

Last updated: February 6, 2017

Last verified: February 2017

History of Changes

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: 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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Genetic and Rare Diseases Information Center resources: Familial 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 ]

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


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

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

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 )
Study First Received:	January 9, 2009
Last Updated:	February 6, 2017
Individual Participant Data
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:


Atrial Fibrillation Tachycardia Arrhythmias, Cardiac	Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on June 22, 2017

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