Pulmonary Vein Isolation using Robotic navigation: a prospective randomised trial with invasive follow-up
| ISRCTN | ISRCTN55370829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55370829 |
| Protocol serial number | RN/2 |
| Sponsor | University Heart Center Hamburg (Germany) |
| Funder | Investigator initiated and funded (Germany) |
- Submission date
- 27/01/2008
- Registration date
- 29/08/2008
- Last edited
- 29/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Steven
Scientific
Scientific
Martinistr. 52
Hamburg
20249
Germany
| d.steven@uke.uni-hamburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised non-blinded clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | RoboticPVI |
| Study objectives | Non-inferiority trial of robotic navigation (RN) guided pulmonary vein isolation compared to manually steered catheter approach. |
| Ethics approval(s) | Ethics approval received from the Hamburg Ethics Committee on the 5th May 2008 (ref: 2801/2008). |
| Health condition(s) or problem(s) studied | Atrial Fibrillation |
| Intervention | Catheter ablation with colled tip electrode with conduction block of all 4 vein proven by circumferential mapping catheter. |
| Intervention type | Other |
| Primary outcome measure(s) |
Recovery of any pulmonary veins (PVs), measured after a follow up of one year is completed. |
| Key secondary outcome measure(s) |
Peri-/post-procedural complications. |
| Completion date | 03/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key exclusion criteria | 1. Left Atrial (LA) diameter greater than 60 mm 2. Refuse to give written informed consent 3. Non-elegibility for interventional therapy |
| Date of first enrolment | 12/01/2007 |
| Date of final enrolment | 03/01/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Martinistr. 52
Hamburg
20249
Germany
20249
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
