Trials / Completed
CompletedNCT05621187
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
BIO|MASTER.Pamira Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by * demonstrating clinical safety * evaluating performance based on sensing and pacing assessment * collecting additional data of interest to assess other aspects such as the handling and usability
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pamira ICD lead family | Implantation, measurements and follow-up schedule |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2025-01-20
- Completion
- 2025-01-20
- First posted
- 2022-11-17
- Last updated
- 2025-02-26
Locations
23 sites across 8 countries: Australia, Austria, Belgium, Germany, Hungary, Israel, Latvia, Slovakia
Source: ClinicalTrials.gov record NCT05621187. Inclusion in this directory is not an endorsement.