Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
NCT ID: NCT02922036
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2018-01-17
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment
WiSE System therapy ON with Guideline Directed Medical Therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
2. Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to \< 150ms
3. Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
2. Patient is a:
1. '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
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
3. Patients on a stable Guideline Directed Medical Therapy (GDMT)
4. Patient must be 18 years old or over
5. Patient has signed and dated informed consent
6. 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)
Exclusion Criteria
1. Pure RBBB
2. LVEDD ≥ 8cm
3. Non-ambulatory or unstable NYHA class IV
4. Contraindication to heparin, chronic anticoagulants or antiplatelet agents
5. Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
6. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
7. Patients with planned or expected lithotripsy treatment post implant
8. Life expectancy of \< 12 months
9. Chronic hemodialysis
10. Stage 4 or 5 renal dysfunction defined as eGFR \< 30
11. Grade 4 mitral valve regurgitation
12. Noncardiac implanted electrical stimulation therapy devices
13. Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
14. Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
15. Unstable angina, acute MI, CABG, or PTCA within the past 1 month
16. Correctable valvular disease that is the primary cause of heart failure
17. Recent CVA or TIA (within the previous 3 months)
18. 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.
19. Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing \<95%)
20. Already included in another clinical study that could confound the results of this study
21. Pregnancy
22. Known drug or alcohol addiction or abuse
23. Moderate or severe aortic stenosis
24. 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
25. For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
18 Years
ALL
Yes
Sponsors
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EBR Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jagmeet Singh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Mary N Walsh, MD, MACC
Role: PRINCIPAL_INVESTIGATOR
St. Vincent Heart Center
Locations
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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
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
Rutgers University
New Brunswick, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Weill Cornell Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
PeaceHealth
Springfield, Oregon, United States
Penn State Health, Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States
MUSC Gazes Research Institute
Charleston, South Carolina, United States
Stern Cardiovascular Center
Germantown, Tennessee, United States
Texas Heart Institute
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Houston Methodist
Sugar Land, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Healthcare
Norfolk, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Heart
Clayton, Victoria, Australia
Royal Melbourne Hospital / Royal Hobart Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
CHU Grenoble - Hopital Michallon Service de Cardiologie
Grenoble, , France
Centre Cardiologique du Nord
Paris, , France
CHU-Hopital Pontchaillou
Rennes, , France
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
Bernau, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)
Hamburg, , Germany
Policlinico S. Orsola
Bologna, , Italy
Ospedale San Gerardo
Monza, , Italy
Isala Hartcentrum
Zwolle, , Netherlands
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Barts Heart Centre
London, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
Manchester Heart Centre
Manchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Singh JP, Abraham WT, Auricchio A, Delnoy PP, Gold M, Reddy VY, Sanders P, Lindenfeld J, Rinaldi CA. Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart J. 2019 Nov;217:13-22. doi: 10.1016/j.ahj.2019.04.002. Epub 2019 Apr 9.
Related Links
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Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure
Other Identifiers
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CSP-03035
Identifier Type: -
Identifier Source: org_study_id
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