Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Running, not enrolling · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT02922036
Run by: EBR Systems, Inc.
People needed: 300
Starts: 2018-01-17
Expected to finish: 2026-06-01
Last updated by the study team: 2025-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
Patient is a:
'Non-responder' [Not Enrolling]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
EF has remained unchanged or worsened (defined as < 5% increase since implant), and
The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee
OR
'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons:
i. Patients in whom CS lead implantation for CRT has failed
CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges
ii. CS lead implanted but has been programmed OFF
LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location
OR
c. 'High Risk Upgrade:
Patients who have a relative contraindication to CS lead implant, due to:
venous occlusion or lesion precluding implant
pocket infection risk (at co-implanted device site)
considered high risk for CS implant due to co-morbidities
Patients on a stable Guideline Directed Medical Therapy (GDMT)
Patient must be 18 years old or over
Patient has signed and dated informed consent
Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant)

You may not qualify if…

Patients who meet any one of these criteria will be excluded from the investigation:
Pure RBBB
LVEDD ≥ 8cm
Non-ambulatory or unstable NYHA class IV
Contraindication to heparin, chronic anticoagulants or antiplatelet agents
Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
Patients with planned or expected lithotripsy treatment post implant
Life expectancy of < 12 months
Chronic hemodialysis
Stage 4 or 5 renal dysfunction defined as eGFR < 30
Grade 4 mitral valve regurgitation
Noncardiac implanted electrical stimulation therapy devices
Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
Unstable angina, acute MI, CABG, or PTCA within the past 1 month
Correctable valvular disease that is the primary cause of heart failure
Recent CVA or TIA (within the previous 3 months)
Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
Already included in another clinical study that could confound the results of this study
Pregnancy
Known drug or alcohol addiction or abuse
Moderate or severe aortic stenosis
Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures

Where it is running

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 — St. Petersburg, Florida, United States
Piedmont Heart Institute — Atlanta, Georgia, United States
Emory Healthcare — Atlanta, Georgia, United States
Prairie Heart — Springfield, Illinois, United States
St. Vincent's Hospital and Healthcare Center — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, United States
Saint Luke's Health System Kansas City — Kansas City, Kansas, United States
The University of Kansas Medical Center — Kansas City, Kansas, United States
Baptist Health Lexington — Lexington, Kentucky, United States
Ochsner Medical Center - Baton Rouge — Baton Rouge, Louisiana, United States
University of Michigan — Ann Arbor, Michigan, United States
Michigan Heart — Canton, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States
William Beaumont Hospital — Hazel Park, Michigan, United States
Sparrow Hospital — Lansing, Michigan, United States
Minneapolis Heart Institute — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
United Heart and Vascular Clinic — Saint Paul, Minnesota, United States
Methodist Physicians Clinic Heart Consultants — Omaha, Nebraska, United States
Heart Center Research — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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