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Heart FailureSOLVE-CRTNCT02922036

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

A study testing WiSE System in people with Heart Failure, run by EBR Systems, Inc. at 68 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
WiSE System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
68 sitesin 7 countries
Study dates
17 Jan 2018to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • a.'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:
Show all 20Show fewer
  • 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
  • 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
  • '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)

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States43 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory Healthcare

    Atlanta, Georgia, 30322

  • Ochsner Medical Center - Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Michigan Heart

    Canton, Michigan, 48188

  • MUSC Gazes Research Institute

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • William Beaumont Hospital

    Hazel Park, Michigan, 48030

  • Penn State Health, Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Texas Heart Institute

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Heart Center Research

    Huntsville, Alabama, 35801

  • St. Vincent's Hospital and Healthcare Center

    Indianapolis, Indiana, 46290

  • University of Iowa

    Iowa City, Iowa, 52242

  • St. Vincent's Healthcare

    Jacksonville, Florida, 32204

  • Saint Luke's Health System Kansas City

    Kansas City, Kansas, 63131

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California, San Diego

    La Jolla, California, 92037

  • Watson Clinic

    Lakeland, Florida, 33805

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Naples Community Hospital

    Naples, Florida, 34102

  • Rutgers University

    New Brunswick, New Jersey, 08901

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Sentara Healthcare

    Norfolk, Virginia, 23507

  • Methodist Physicians Clinic Heart Consultants

    Omaha, Nebraska, 68114

  • UPMC Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102

  • Prairie Heart

    Springfield, Illinois, 62769

  • PeaceHealth

    Springfield, Oregon, 97477

  • Northside Hospital and Heart Institute

    St. Petersburg, Florida, 33709

  • Houston Methodist

    Sugar Land, Texas, 77479

Other trials in United States

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • The Prince Charles Hospital

    Chermside, Queensland

  • Monash Heart

    Clayton, Victoria, 3168

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal Melbourne Hospital / Royal Hobart Hospital

    Parkville, Victoria

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Sydney Adventist Hospital

    Wahroonga, New South Wales

Other trials in Australia

United Kingdom6 sites

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • Barts Heart Centre

    London, EC1A 7BE

  • St. Thomas Hospital

    London, SE1 7EH

  • Manchester Heart Centre

    Manchester, M13 9WL

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • John Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

France3 sites

  • CHU Grenoble - Hopital Michallon Service de Cardiologie

    Grenoble

  • Centre Cardiologique du Nord

    Paris

  • CHU-Hopital Pontchaillou

    Rennes

Other trials in France

Germany3 sites

  • Immanuel Klinikum Bernau - Herzzentrum Brandenburg

    Bernau, 16321

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)

    Hamburg

Other trials in Germany

Italy2 sites

  • Policlinico S. Orsola

    Bologna, 40138

  • Ospedale San Gerardo

    Monza

Other trials in Italy

Netherlands1 site

  • Isala Hartcentrum

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

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.

Read the 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.

Conditions
Heart Failure
Being tested
WiSE System
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WiSE SystemDevice

    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.

Study groups in NCT02922036
Study groupRoleWhat they receive
TreatmentExperimentalWiSE System therapy ON with Guideline Directed Medical Therapy
Receives: Device: WiSE System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety

    Freedom from Procedure and Device System related Type 1 Complications

    Measured: 6 Months

  2. Primary Efficacy 1

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

    Measured: 6 Months

Secondary outcomes (5)

  1. Secondary Efficacy 1

    Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit

    Measured: 6 Months

  2. Secondary Efficacy 2

    Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit

    Measured: 6 Months

  3. Secondary Efficacy 3

    % Bi-ventricular pacing at 6 months

    Measured: 6 months

  4. Secondary Efficacy 4

    EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.

    Measured: 6 months

  5. Secondary Efficacy 5

    KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study start17 Jan 2018
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922036
Sponsor's protocol ID
CSP-03035
Acronym
SOLVE-CRT
Status last verified
Oct 2026
First submitted
27 Sep 2016
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31472360

Questions about this trial

What is this clinical trial studying?

A study testing WiSE System in people with Heart Failure, run by EBR Systems, Inc. at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Australia, United Kingdom, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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