Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

NCT02922036 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CSP-03035
• Study Type: interventional
• Target: 300
• Locations: 7 countries
• Sites: 68

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Primary Safety

  Freedom from Procedure and Device System related Type 1 Complications

  6 Months

• Primary Efficacy 1

  Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.

  6 Months

Secondary Outcomes (5)

• Secondary Efficacy 1

  6 Months

• Secondary Efficacy 2

  6 Months

• Secondary Efficacy 3

  6 months

• Secondary Efficacy 4

  6 months

• Secondary Efficacy 5

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

WiSE System therapy ON with Guideline Directed Medical Therapy

Device: WiSE System

Interventions

WiSE System DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not 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
• 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
• c. 'High Risk Upgrade:
• Patients who have a relative contraindication to CS lead implant, due to:
• venous occlusion or lesion precluding implant

Sponsors & Collaborators

• EBR Systems, Inc.: lead

Study Sites (68)

Heart Center Research

Huntsville, Alabama, 35801, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

St. Vincent's Healthcare

Jacksonville, Florida, 32204, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

Northside Hospital and Heart Institute

St. Petersburg, Florida, 33709, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

Prairie Heart

Springfield, Illinois, 62769, United States

Location

St. Vincent's Hospital and Healthcare Center

Indianapolis, Indiana, 46290, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Saint Luke's Health System Kansas City

Kansas City, Kansas, 63131, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Ochsner Medical Center - Baton Rouge

Baton Rouge, Louisiana, 70816, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Michigan Heart

Canton, Michigan, 48188, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Hazel Park, Michigan, 48030, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, 68114, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

PeaceHealth

Springfield, Oregon, 97477, United States

Location

Penn State Health, Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MUSC Gazes Research Institute

Charleston, South Carolina, 29425, United States

Location

Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Houston Methodist

Sugar Land, Texas, 77479, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Sentara Healthcare

Norfolk, Virginia, 23507, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Heart

Clayton, Victoria, 3168, Australia

Location

Royal Melbourne Hospital / Royal Hobart Hospital

Parkville, Victoria, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

CHU Grenoble - Hopital Michallon Service de Cardiologie

Grenoble, France

Location

Centre Cardiologique du Nord

Paris, France

Location

CHU-Hopital Pontchaillou

Rennes, France

Location

Immanuel Klinikum Bernau - Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)

Hamburg, Germany

Location

Policlinico S. Orsola

Bologna, 40138, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

Isala Hartcentrum

Zwolle, 8025 AB, Netherlands

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Manchester Heart Centre

Manchester, M13 9WL, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31472360 DERIVED

Related Links

• Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jagmeet Singh, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mary N Walsh, MD, MACC

  St. Vincent Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: One part of the study was randomized. The final part of the study was single-arm, open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 3, 2016
• Study Start: January 17, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10); NL (1); GB (6); US (43); IT (2); DE (3); FR (3)