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

March 6, 2018 updated by: Dr. Kai Jaquet

Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom of AF 12 months after procedure.
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Kai Jaquet

Collaborators

Abbott Medical Devices
Hansen Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

February 27, 2018

Study Completion (ACTUAL)

February 27, 2018

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (ESTIMATE)

September 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1889

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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