Trials / Completed
CompletedNCT02097290
Evaluation of Automatic Threshold Algorithms
CAPTure Information Via Automatic Threshold Evaluation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.
Detailed description
The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRT-D | For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-01-01
- Completion
- 2017-05-01
- First posted
- 2014-03-27
- Last updated
- 2018-04-19
- Results posted
- 2017-09-01
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02097290. Inclusion in this directory is not an endorsement.