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

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ClinicalTrials.gov Identifier: NCT00982475
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
St. Jude Medical
Hansen Medical
Information provided by (Responsible Party):
Dr. Kai Jaquet, Asklepios proresearch

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 Phase
Atrial Fibrillation Procedure: Pulmonary vein isolation with radiofrequency current Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine


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




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


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
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

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


Locations
Germany
ASKLEPIOS KLINIK St. Georg
Hamburg, Germany, 20099
Sponsors and Collaborators
Dr. Kai Jaquet
St. Jude Medical
Hansen Medical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kai Jaquet, Prof. Dr. Roland Richard Tilz, Asklepios proresearch
ClinicalTrials.gov Identifier: NCT00982475     History of Changes
Other Study ID Numbers: 1889
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Dr. Kai Jaquet, Asklepios proresearch:
pulmonary vein isolation
robotic navigation
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes