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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 because the information has not been verified recently.
Verified June 2011 by Asklepios proresearch.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St. Jude Medical
Hansen Medical
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT00982475
First received: September 22, 2009
Last updated: June 21, 2011
Last verified: June 2011
  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:


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
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: 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014