NCT00982475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

8.5 years

First QC Date

September 22, 2009

Last Update Submit

March 6, 2018

Conditions

Atrial Fibrillation

Keywords

pulmonary vein isolationrobotic navigationatrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Freedom of AF 12 months after procedure.

    12 month

Study Arms (2)

PVI with robotic navigation

ACTIVE COMPARATOR
Procedure: Pulmonary vein isolation with radiofrequency current

PVI manually

PLACEBO COMPARATOR
Procedure: Pulmonary vein isolation with radiofrequency current

Interventions

Pulmonary vein isolation with radiofrequency currentPROCEDURE

Pulmonary vein isolation with radiofrequency current

PVI manuallyPVI with robotic navigation

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • paroxysmal atrial fibrillation
  • persistent atrial fibrillation \< 2 month
  • indication for catheter ablation
  • LEF \> 50%
  • diameter LA \< 50 mm

You may not qualify if:

  • intracardial thrombus
  • atrial fibrillation with underlying curable disease
  • renal failure \> stage I
  • contraindication for anticoagulation
  • life expectancy \< 12 month
  • previous PVI
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASKLEPIOS KLINIK St. Georg

Hamburg, 20099, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29759785DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Roland Richard Tilz

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

September 1, 2009

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

DE(1)