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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00982475
Recruitment Status : Unknown
Verified June 2011 by Asklepios proresearch.
Recruitment status was:  Recruiting
First Posted : September 23, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Atrial Fibrillation Procedure: Pulmonary vein isolation with radiofrequency current

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Freedom of AF 12 months after procedure. [ Time Frame: 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

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