Trials / Active Not Recruiting
Active Not RecruitingNCT02922036
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- EBR Systems, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
Detailed description
The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WiSE System | The WiSE System is an implantable cardiac system to provide LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation. |
Timeline
- Start date
- 2018-01-17
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2016-10-03
- Last updated
- 2025-07-09
Locations
68 sites across 7 countries: United States, Australia, France, Germany, Italy, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02922036. Inclusion in this directory is not an endorsement.