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Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (SOLVE-CRT)

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ClinicalTrials.gov Identifier: NCT02922036
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date December 2, 2021
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
  • Primary Safety [ Time Frame: 6 Months ]
    Freedom from Procedure and Device System related Type 1 Complications
  • Primary Efficacy 1 [ Time Frame: 6 Months ]
    Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Primary Safety [ Time Frame: 6 Months ]
    Freedom from Procedure and Device System related Type 1 Complications, Includes Electrode related complications such as dislodgement, migration, or malfunction; Vascular related complications that are procedure related (e.g. AV fistula, retroperitoneal bleed, pseudo aneurysm of the femoral artery, and bleeding requiring invasive correction or blood products); Transmitter/Battery pocket complications (e.g. infection, hematoma); and Stroke/TIA
  • Primary Efficacy 1 [ Time Frame: 6 Months ]
    Mean change in Left Ventricular End Systolic Volume (LVESV) compared between arms (baseline to 6 Months). Measure in mili-liter difference between arms.
  • Primary Efficacy 2 [ Time Frame: 6 Months ]
    LVESV Distribution Shift, defined as the percentage of subjects with an improvement of greater than 15% in LVESV, compared between arms (baseline to 6 Months)
  • Primary Efficacy 3 [ Time Frame: 6 Months ]
    Proportion of subjects improved on a clinical composite compared between arms (baseline to 6 Months). Measure of New York Class Association (NYHA), Quality of Life (QOL), Heart Failure (HF) Events and death.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
  • Secondary Efficacy 1 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit
  • Secondary Efficacy 2 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit
  • Secondary Efficacy 3 [ Time Frame: 6 months ]
    % Bi-ventricular pacing (total number of WiSE paced beats / total number of co-implant RV-paced beats) at 6 months
  • Secondary Efficacy 4 [ Time Frame: 6 months ]
    EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.
  • Secondary Efficacy 5 [ Time Frame: 6 months ]
    KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Secondary Efficacy 1 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold (APCT) measured from predischarge through the 6-month follow-up post-implant visit (in the Treatment arm). The secondary efficacy APCT endpoint has a criteria of attainment of an APCT less than or equal to 2.9 milli-joules (mJ).
  • Secondary Efficacy 2 [ Time Frame: 6 Months ]
    Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from predischarge through the 6-month follow-up post-implant visit (in the Treatment arm). Demonstration of APCT stability through 6 months, is defined as a less than 3x relative change from predischarge in APCT.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 29, 2016)
  • Tertiary Efficacy 1 [ Time Frame: 6 Months ]
    The mean change in NT-proBNP from baseline, compared between arms (baseline to 6 months
  • Tertiary Efficacy 2 [ Time Frame: 6 Months ]
    The proportion of subjects with a greater than 5% change in EF, compared between arms (baseline through 6 months)
  • Tertiary Efficacy 3 [ Time Frame: 6 Months ]
    The mean change in intrinsic QRS duration, compared between arms (baseline to 6 months)
  • Tertiary Efficacy 4 [ Time Frame: 6 Months ]
    The percent subjects with at least a one class improvement in NYHA, compared between arms (baseline to 6 months)
 
Descriptive Information
Brief Title  ICMJE Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Official Title  ICMJE Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: Treatment
WiSE System therapy ON with Guideline Directed Medical Therapy
Intervention: Device: WiSE System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2021)
192
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
350
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion/Exclusion:

Inclusion Criteria

  1. 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)):

    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

    2. '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
  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

Patients who meet any one of these criteria will be excluded from the investigation:

  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. Positive test for COVID-19 at screening
  25. 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
  26. For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Paulette Niemyski 6307405721 paulette.niemyski@ebrsystemsinc.com
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT02922036
Other Study ID Numbers  ICMJE CSP-03035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EBR Systems, Inc.
Study Sponsor  ICMJE EBR Systems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jagmeet Singh, MD, PhD Massachusetts General Hospital
Principal Investigator: Mary N Walsh, MD, MACC St. Vincent Heart Center
PRS Account EBR Systems, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP