Trials / Completed
CompletedNCT03294317
Imaging Study of Lead Implant for His Bundle Pacing
Imagining Study of Lead Implant for His Bundle Pacing
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.
Detailed description
The study will evaluate implant lead electrical measurements and changes over time, estimate the correlation between lead location and selective vs non-selective His bundle pacing, and estimate the correlation between long-term lead performance and implant characteristics. Data from the study may be used to standardize the implant workflow to help improve the ease and predictability of His bundle pacing implants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | His bundle pacing | Medtronic SelectSecure SureScan MRI model 3830 lead |
Timeline
- Start date
- 2017-11-29
- Primary completion
- 2019-04-24
- Completion
- 2020-01-24
- First posted
- 2017-09-27
- Last updated
- 2021-06-01
- Results posted
- 2021-06-01
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03294317. Inclusion in this directory is not an endorsement.