Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02922036
NCT02922036Active, not recruitingNot 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.127 sites in 2 countries300 target enrollmentStarted: January 17, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
127
Primary Endpoint
Primary Efficacy 1
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Masking Description

One part of the study was randomized. The final part of the study was single-arm, open label.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (127)

Loading locations...

Similar Trials

Completed
Not Applicable
Wireless Stimulation Endocardially for Cardiac Resynchronization TherapyVentricular DysfunctionHeart FailureCardiomyopathy
NCT01294527EBR Systems, Inc.17
Completed
Not Applicable
Safety and Effectiveness Study of the Solysafe Septal OccluderAtrial Septal Defects
NCT00353509Carag AG
Completed
Not Applicable
The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE TrialChronic Heart Failure
NCT01166347Medtronic Cardiac Rhythm and Heart Failure451
Active, not recruiting
Not Applicable
Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart FailureEnd-stage Heart Failure
NCT02592499Vastra Gotaland Region74
Completed
Not Applicable
A Trial of Rehabilitation Paired With VNS for Motor Function in Patients With Stroke (Repair Study)Ischemic StrokeUpper Extremity Paresis
NCT06722677Beijing Pins Medical Co., Ltd99