SOLVE-CRT: Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- Primary Safety [6 Months]
Freedom from Procedure and Device System related Type 1 Complications
- Primary Efficacy 1 [6 Months]
Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Secondary Outcome Measures
- Secondary Efficacy 1 [6 Months]
Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit
- 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
- 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
- Secondary Efficacy 4 [6 months]
EF responder analysis for ≥ 5% absolute increase from baseline to 6 months.
- Secondary Efficacy 5 [6 months]
KCCQ responder analysis for ≥ 5 points absolute increase from baseline to 6 months
Eligibility Criteria
Criteria
Inclusion/Exclusion:
Inclusion Criteria
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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)):
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Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
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Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
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Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
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Patient is a:
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'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:
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EF has remained unchanged or worsened (defined as < 5% increase since implant), and
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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
OR
- 'High Risk Upgrade:
Patients who have a relative contraindication to CS lead implant, due to:
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venous occlusion or lesion precluding implant
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pocket infection risk (at co-implanted device site)
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considered high risk for CS implant due to co-morbidities
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Patients on a stable Guideline Directed Medical Therapy (GDMT)
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Patient must be 18 years old or over
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Patient has signed and dated informed consent
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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:
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Pure RBBB
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LVEDD ≥ 8cm
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Non-ambulatory or unstable NYHA class IV
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Contraindication to heparin, chronic anticoagulants or antiplatelet agents
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Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
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Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
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Patients with planned or expected lithotripsy treatment post implant
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Life expectancy of < 12 months
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Chronic hemodialysis
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Stage 4 or 5 renal dysfunction defined as eGFR < 30
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Grade 4 mitral valve regurgitation
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Noncardiac implanted electrical stimulation therapy devices
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Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
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Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
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Unstable angina, acute MI, CABG, or PTCA within the past 1 month
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Correctable valvular disease that is the primary cause of heart failure
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Recent CVA or TIA (within the previous 3 months)
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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.
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Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
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Already included in another clinical study that could confound the results of this study
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Pregnancy
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Known drug or alcohol addiction or abuse
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Moderate or severe aortic stenosis
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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
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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 | |
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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.- CSP-03035