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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

NCT02922036 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • EBR Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jagmeet Singh, MD, PhD · Massachusetts General Hospital

  • Mary N Walsh, MD, MACC · St. Vincent Heart Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922036 on ClinicalTrials.gov