Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (SOLVE-CRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02922036|
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: WiSE System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2025|
WiSE System therapy ON with Guideline Directed Medical Therapy
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.
- Primary Safety [ Time Frame: 6 Months ]Freedom from Procedure and Device System related Type 1 Complications
- Primary Efficacy 1 [ Time Frame: 6 Months ]Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
- Secondary Efficacy 1 [ Time Frame: 6 Months ]Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit
- Secondary Efficacy 2 [ Time Frame: 6 Months ]Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit
- Secondary Efficacy 3 [ Time Frame: 6 months ]% Bi-ventricular pacing (total number of WiSE paced beats / total number of co-implant RV-paced beats) at 6 months
- Secondary Efficacy 4 [ Time Frame: 6 months ]EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.
- Secondary Efficacy 5 [ Time Frame: 6 months ]KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922036
|Contact: Paulette Niemyskifirstname.lastname@example.org|
|Principal Investigator:||Jagmeet Singh, MD, PhD||Massachusetts General Hospital|
|Principal Investigator:||Mary N Walsh, MD, MACC||St. Vincent Heart Center|