Trials / Completed
CompletedNCT03922386
Safety and Electrical Performances of XFINE Leads
ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- MicroPort CRM · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.
Detailed description
All subjects will be followed until 12 months follow-up post implant. At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XFINE leads | Pacemaker subjects with at least one XFINE passive lead |
Timeline
- Start date
- 2019-09-09
- Primary completion
- 2021-03-25
- Completion
- 2021-07-23
- First posted
- 2019-04-22
- Last updated
- 2023-04-06
Locations
19 sites across 5 countries: France, Italy, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03922386. Inclusion in this directory is not an endorsement.