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

NCT ID: NCT00982475

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2018-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVI with robotic navigation

Group Type ACTIVE_COMPARATOR

Pulmonary vein isolation with radiofrequency current

Intervention Type PROCEDURE

Pulmonary vein isolation with radiofrequency current

PVI manually

Group Type PLACEBO_COMPARATOR

Pulmonary vein isolation with radiofrequency current

Intervention Type PROCEDURE

Pulmonary vein isolation with radiofrequency current

Interventions

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Pulmonary vein isolation with radiofrequency current

Pulmonary vein isolation with radiofrequency current

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Hansen Medical

INDUSTRY

Sponsor Role collaborator

Dr. Kai Jaquet

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Kai Jaquet

Prof. Dr. Roland Richard Tilz

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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ASKLEPIOS KLINIK St. Georg

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29759785 (View on PubMed)

Other Identifiers

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1889

Identifier Type: -

Identifier Source: org_study_id

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