Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-003014
    NCT ID: NCT02922036
    Sponsor Protocol Number: CSP-03035

About this study

This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization Therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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’:
      • 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 remaining clinically unchanged or worsened:
        • 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:
    • 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.

† EF used for inclusion criteria and for the Baseline TTE must be measured under these conditions:

  • Non-responder Patients: EF measured with BiV ON;
  • Previously Untreatable Patients: EF measured with CS Lead OFF (if it exists), or in baseline state (if CS lead does not exist);
  • High Risk Upgrade Patients: EF measured in baseline state.

‡ QRS used for inclusion criteria should be measured as the patient presents: Non-responder Patients: BiV QRS, Previously untreatable, high risk upgrade – either intrinsic or RV QRS – patient in their current, optimized state.

§ The CS Lead must be programmed OFF during SOLVE CRT screening.

OR

‘High risk upgrades:  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 GDMTGuideline Directed Medical Therapy (GDMT).
  • Patient is in sinus rhythm.
  • 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).

Exclusion Criteria

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 1 monthprior 30 days.
  • Patients receivingwith planned or expected lithotripsy treatment post implant.
  • Life expectancy of < 12 months.
  • Chronic hemodialysis.
  • Stage 4 or 5 renal dysfunction defined as GFR
  • Grade 4 mitral valve regurgitation.
  • Noncardiac implanted electrical stimulation therapy devices.
  • Mechanical aortic valves or TAVR valves*.
  • 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).
  • Atrial fibrillation/flutter: Patients with a history of paroxysmal or persistent atrial fibrillation/flutter may be included if they have been in sinus rhythm for the past 30 days, and have not had cardioversion in the past 30 days. Patients with AV node ablation may be included if they have not had symptomatic atrial fibrillation/flutter in the last 30 days, and have not had cardioversion in the past 30 days.
  • 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.
  • Patient will not tolerate being randomized to the Control Group for 6 months.  

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yong-Mei Cha, M.D.

Open for enrollment

Contact information:

Yongmei Cha M.D.

(507)255-7369

ycha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20343898

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