Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulmonary vein isolation with radiofrequency current
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring pulmonary vein isolation, robotic navigation, atrial fibrillation
Eligibility 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
Sites / Locations
- ASKLEPIOS KLINIK St. Georg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
PVI with robotic navigation
PVI manually
Arm Description
Outcomes
Primary Outcome Measures
Freedom of AF 12 months after procedure.
Secondary Outcome Measures
Full Information
NCT ID
NCT00982475
First Posted
September 22, 2009
Last Updated
March 6, 2018
Sponsor
Dr. Kai Jaquet
Collaborators
Abbott Medical Devices, Hansen Medical
1. Study Identification
Unique Protocol Identification Number
NCT00982475
Brief Title
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Official Title
Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Kai Jaquet
Collaborators
Abbott Medical Devices, Hansen Medical
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
pulmonary vein isolation, robotic navigation, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI with robotic navigation
Arm Type
Active Comparator
Arm Title
PVI manually
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation with radiofrequency current
Intervention Description
Pulmonary vein isolation with radiofrequency current
Primary Outcome Measure Information:
Title
Freedom of AF 12 months after procedure.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
ASKLEPIOS KLINIK St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29759785
Citation
Rillig A, Schmidt B, Di Biase L, Lin T, Scholz L, Heeger CH, Metzner A, Steven D, Wohlmuth P, Willems S, Trivedi C, Galllinghouse JG, Natale A, Ouyang F, Kuck KH, Tilz RR. Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial. JACC Clin Electrophysiol. 2017 Aug;3(8):875-883. doi: 10.1016/j.jacep.2017.01.024. Epub 2017 Jun 28.
Results Reference
derived
Learn more about this trial
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
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