Clinical trial NCT02922036: Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Official title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: EBR Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. 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

Primary outcomes:
measure: Primary Safety
timeFrame: 6 Months
measure: Primary Efficacy 1
timeFrame: 6 Months
Secondary outcomes:
measure: Secondary Efficacy 1
timeFrame: 6 Months
measure: Secondary Efficacy 2
timeFrame: 6 Months
measure: Secondary Efficacy 3
timeFrame: 6 months
measure: Secondary Efficacy 4
timeFrame: 6 months
measure: Secondary Efficacy 5
timeFrame: 6 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Healthcare
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital and Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Springfield
country: United States
facility: Prairie Heart
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospital and Healthcare Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Saint Luke's Health System Kansas City
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Medical Center - Baton Rouge
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Canton
country: United States
facility: Michigan Heart
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Hazel Park
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Omaha
country: United States
facility: Methodist Physicians Clinic Heart Consultants
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Springfield
country: United States
facility: PeaceHealth
state: Oregon
city: Hershey
country: United States
facility: Penn State Health, Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Institute
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Gazes Research Institute
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Center
state: Tennessee
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Healthcare
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital
state: Canberra
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Heart
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital / Royal Hobart Hospital
state: Victoria
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon Service de Cardiologie
city: Paris
country: France
facility: Centre Cardiologique du Nord
city: Rennes
country: France
facility: CHU-Hopital Pontchaillou
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)
city: Bologna
country: Italy
facility: Policlinico S. Orsola
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Zwolle
country: Netherlands
facility: Isala Hartcentrum
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Barts Heart Centre
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Centre
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Jagmeet Singh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent Heart Center
name: Mary N Walsh, MD, MACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.