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

Sponsor
EBR Systems, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02922036
Collaborator
(none)
192
60
1
94.5
3.2
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: WiSE System
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
Actual Study Start Date :
Jan 17, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

WiSE System therapy ON with Guideline Directed Medical Therapy

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.

Outcome Measures

Primary Outcome Measures

  1. Primary Safety [6 Months]

    Freedom from Procedure and Device System related Type 1 Complications

  2. Primary Efficacy 1 [6 Months]

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

Secondary Outcome Measures

  1. Secondary Efficacy 1 [6 Months]

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

  2. Secondary Efficacy 2 [6 Months]

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

  3. Secondary Efficacy 3 [6 months]

    % Bi-ventricular pacing (total number of WiSE paced beats / total number of co-implant RV-paced beats) at 6 months

  4. Secondary Efficacy 4 [6 months]

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

  5. Secondary Efficacy 5 [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)):

  2. Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms

  3. Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms

  4. Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms

  5. Patient is a:

  6. '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

  1. '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:
  1. 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
  1. 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

  1. '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

  1. Patients on a stable Guideline Directed Medical Therapy (GDMT)

  2. Patient must be 18 years old or over

  3. Patient has signed and dated informed consent

  4. 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. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner University Medical Center Phoenix Arizona United States 85006
2 Keck Medical Center of USC Los Angeles California United States 90033
3 Sequoia Hospital Redwood City California United States 94062
4 Yale University New Haven Connecticut United States 06519
5 Broward Health Medical Center Fort Lauderdale Florida United States 33316
6 St. Vincent's Healthcare Jacksonville Florida United States 32204
7 Piedmont Heart Institute Atlanta Georgia United States 30309
8 Emory Healthcare Atlanta Georgia United States 30322
9 Prairie Heart Springfield Illinois United States 62769
10 St. Vincent's Hospital and Healthcare Center Indianapolis Indiana United States 46290
11 University of Iowa Iowa City Iowa United States 52242
12 Baptist Health Lexington Lexington Kentucky United States 40503
13 Massachusetts General Hospital Boston Massachusetts United States 02114
14 Henry Ford Hospital Detroit Michigan United States 48202
15 Sparrow Hospital Lansing Michigan United States 48912
16 Mayo Clinic Rochester Minnesota United States 55905
17 United Heart and Vascular Clinic Saint Paul Minnesota United States 55102
18 Methodist Physicians Heart Clinic Consultants Omaha Nebraska United States 68114
19 Mount Sinai Hospital New York New York United States 10029
20 Weill Cornell Medical Center New York New York United States 10065
21 Cleveland Clinic Cleveland Ohio United States 44195
22 The Ohio State University Columbus Ohio United States 43210
23 UPMC Heart and Vascular Institute Pittsburgh Pennsylvania United States 15213
24 MUSC Gazes Research Institute Charleston South Carolina United States 29425
25 Stern Cardiovascular Center Germantown Tennessee United States 38138
26 Stern Cardiovascular Germantown Tennessee United States 38138
27 Texas Heart Institute Houston Texas United States 77030
28 The University of Texas Health Science Center at Houston Houston Texas United States 77030
29 The Heart Hospital Baylor Plano Plano Texas United States 75093
30 Houston Methodist Sugar Land Texas United States 77479
31 University of Virginia Charlottesville Virginia United States 22903
32 Sentara Norfolk Virginia United States 23507
33 VCU Medical Center Richmond Virginia United States 23298
34 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
35 Canberra Hospital Garran Canberra Australia 2605
36 John Hunter Hospital New Lambton Heights New South Wales Australia 2305
37 Prince of Wales Hospital Randwick New South Wales Australia 2031
38 Royal Adelaide Hospital Adelaide South Australia Australia 5000
39 Monash Heart Clayton Victoria Australia 3168
40 The Alfred Hospital Melbourne Victoria Australia 3004
41 Fiona Stanley Hospital Perth Western Australia Australia 6150
42 Royal Prince Alfred Hospital Camperdown Australia 2050
43 CHU Grenoble - Hopital Michallon Service de Cardiologie Grenoble France
44 APHM-Hopital de La Timone Marseille France
45 Centre Cardiologique du Nord Paris France
46 CHU-Hopital Pontchaillou Rennes France
47 Clinique Pasteur Cardiologie & Rythmologie Toulouse France
48 Immanuel Klinikum Bernau - Herzzentrum Brandenburg Bernau Germany 16321
49 Universitätsklinikum Erlangen Erlangen Germany 91054
50 Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ) Hamburg Germany
51 Universitätsklinikum Münster Münster Germany 48149
52 Policlinico S. Orsola - Malpighi Bologna Italy 40138
53 Ospedale San Gerardo Monza Italy
54 Isala Hartcentrum Zwolle Netherlands 8025 AB
55 Liverpool Heart and Chest Hospital Liverpool United Kingdom L14 3PE
56 Barts Heart Centre London United Kingdom EC1A 7BE
57 St. Thomas' Hospital London United Kingdom SE1 7EH
58 Manchester Heart Centre Manchester United Kingdom M13 9WL
59 James Cook University Hospital Middlesbrough United Kingdom TS4 3BW
60 John Radcliffe Hospital Oxford United Kingdom OX3 9DU

Sponsors and Collaborators

  • EBR Systems, Inc.

Investigators

  • Principal Investigator: Jagmeet Singh, MD, PhD, Massachusetts General Hospital
  • Principal Investigator: Mary N Walsh, MD, MACC, St. Vincent Heart Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EBR Systems, Inc.
ClinicalTrials.gov Identifier:
NCT02922036
Other Study ID Numbers:
  • CSP-03035
First Posted:
Oct 3, 2016
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022