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Clinical Trials/NCT02922036
NCT02922036
Active, not recruiting
Not Applicable

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

EBR Systems, Inc.68 sites in 2 countries300 target enrollmentJanuary 17, 2018
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ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
EBR Systems, Inc.
Enrollment
300
Locations
68
Primary Endpoint
Primary Efficacy 1
Status
Active, not recruiting
Last Updated
9 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 17, 2018
End Date
June 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Primary Efficacy 1

Time Frame: 6 Months

Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.

Primary Safety

Time Frame: 6 Months

Freedom from Procedure and Device System related Type 1 Complications

Secondary Outcomes

  • Secondary Efficacy 2(6 Months)
  • Secondary Efficacy 5(6 months)
  • Secondary Efficacy 3(6 months)
  • Secondary Efficacy 1(6 Months)
  • Secondary Efficacy 4(6 months)

Study Sites (68)

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