Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Not Applicable

Active, not recruiting

• Conditions: Heart Failure

• Registration Number: NCT02922036
• Lead Sponsor: EBR Systems, Inc.

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 Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2018-01-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Primary Efficacy 1	6 Months	Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Primary Safety	6 Months	Freedom from Procedure and Device System related Type 1 Complications

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy 2	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 5	6 months	KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months
Secondary Efficacy 3	6 months	% Bi-ventricular pacing at 6 months
Secondary Efficacy 1	6 Months	Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit
Secondary Efficacy 4	6 months	EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.

Trial Locations

Locations (68)

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Broward Health Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

St. Vincent's Healthcare; 🇺🇸 Jacksonville, Florida, United States

Watson Clinic; 🇺🇸 Lakeland, Florida, United States

Naples Community Hospital; 🇺🇸 Naples, Florida, United States

Northside Hospital and Heart Institute; 🇺🇸 Saint Petersburg, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Emory Healthcare; 🇺🇸 Atlanta, Georgia, United States

Prairie Heart; 🇺🇸 Springfield, Illinois, United States

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