Condition category
Circulatory System
Date applied
27/01/2008
Date assigned
29/08/2008
Last edited
29/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Steven

ORCID ID

Contact details

Martinistr. 52
Hamburg
20249
Germany
d.steven@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RN/2

Study information

Scientific title

Acronym

RoboticPVI

Study hypothesis

Non-inferiority trial of robotic navigation (RN) guided pulmonary vein isolation compared to manually steered catheter approach.

Ethics approval

Ethics approval received from the Hamburg Ethics Committee on the 5th May 2008 (ref: 2801/2008).

Study design

Prospective randomised non-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atrial Fibrillation

Intervention

Catheter ablation with colled tip electrode with conduction block of all 4 vein proven by circumferential mapping catheter.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recovery of any pulmonary veins (PVs), measured after a follow up of one year is completed.

Secondary outcome measures

Peri-/post-procedural complications.

Overall trial start date

12/01/2007

Overall trial end date

03/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Documented, symptomatic atrial fibrillation lasting less than 48 hours
2. No prior history of electrical cardioversion
3. Both genders aged from 18 - 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Left Atrial (LA) diameter greater than 60 mm
2. Refuse to give written informed consent
3. Non-elegibility for interventional therapy

Recruitment start date

12/01/2007

Recruitment end date

03/01/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Martinistr. 52
Hamburg
20249
Germany

Sponsor information

Organisation

University Heart Center Hamburg (Germany)

Sponsor details

Martinistr. 52
Hamburg
20249
Germany
+49 (0)49 42803 4125
info@uke.de

Sponsor type

Hospital/treatment centre

Website

http://www.uke.uni-hamburg.de/zentren/herz/index.php

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes