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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
Dr. Kai Jaquet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring pulmonary vein isolation, robotic navigation, atrial fibrillation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 22, 2009
Last Updated
March 6, 2018
Sponsor
Dr. Kai Jaquet
Collaborators
Abbott Medical Devices, Hansen Medical
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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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