Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

This study is currently recruiting participants.

Verified June 2011 by Asklepios proresearch

First Received on September 22, 2009. Last Updated on June 21, 2011 History of Changes

Sponsor:	Asklepios proresearch
Collaborators:	St. Jude Medical Hansen Medical
Information provided by:	Asklepios proresearch
ClinicalTrials.gov Identifier:	NCT00982475

Purpose

Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.

Condition	Intervention
Atrial Fibrillation	Procedure: Pulmonary vein isolation with radiofrequency current

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:

Freedom of AF 12 months after procedure. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	September 2009
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: PVI with robotic navigation	Procedure: Pulmonary vein isolation with radiofrequency current Pulmonary vein isolation with radiofrequency current
Placebo Comparator: PVI manually	Procedure: Pulmonary vein isolation with radiofrequency current Pulmonary vein isolation with radiofrequency current

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

paroxysmal atrial fibrillation
persistent atrial fibrillation < 2 month
indication for catheter ablation
LEF > 50%
diameter LA < 50 mm

Exclusion Criteria:

intracardial thrombus
atrial fibrillation with underlying curable disease
renal failure > stage I
contraindication for anticoagulation
life expectancy < 12 month
previous PVI
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982475

Contacts

Contact: Roland Tilz, MD	+49/40/181885 ext 4412	r.tilz@asklepios.com
Contact: Cornelia Wolf	+49/40/181885 ext 3069	co.wolf@asklepios.com

Locations

Germany
ASKLEPIOS KLINIK St. Georg	Recruiting
Hamburg, Germany, 20099
Contact: Roland Tilz, MD +49 40 1818 85 ext 4412 r.tilz@asklepios.com
Contact: Cornelia Wolf +49 40 1818 85 ext 3069 co.wolf@asklepios.com
Principal Investigator: Roland Tilz, MD

Sponsors and Collaborators

Asklepios proresearch

St. Jude Medical

Hansen Medical

More Information

No publications provided

Responsible Party:	Roland Tilz/Dr. med., Asklepios Klinik St. Georg, Department of Cardiology
ClinicalTrials.gov Identifier:	NCT00982475 History of Changes
Other Study ID Numbers:	1889
Study First Received:	September 22, 2009
Last Updated:	June 21, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by Asklepios proresearch:

pulmonary vein isolation
robotic navigation
atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012