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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Asklepios proresearch.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982475
First Posted: September 23, 2009
Last Update Posted: June 22, 2011
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.
Collaborators:
St. Jude Medical
Hansen Medical
Information provided by:
Asklepios proresearch
  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: 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

Resource links provided by NLM:


Further study details as provided by Asklepios proresearch:

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: September 22, 2009
First Posted: September 23, 2009
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