Trials / Completed
CompletedNCT03504020
ECG Belt for CRT Response
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 498 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
Detailed description
The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ECG Belt Research System | The ECG Belt Research System is used to identify the best vector and programming parameters. |
Timeline
- Start date
- 2018-07-13
- Primary completion
- 2022-01-07
- Completion
- 2022-04-20
- First posted
- 2018-04-20
- Last updated
- 2023-02-03
- Results posted
- 2023-02-03
Locations
43 sites across 7 countries: United States, Belgium, Canada, Denmark, Italy, Netherlands, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03504020. Inclusion in this directory is not an endorsement.