Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Heart Failure Clinical Trial

— SOLVE-CRT  

Official title:

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02922036
• Other study ID #: CSP-03035
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: EBR Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EBR Systems, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety	Freedom from Procedure and Device System related Type 1 Complications	6 Months
Primary	Primary Efficacy 1	Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.	6 Months
Secondary	Secondary Efficacy 1	Electrode Acoustic Pacing Capture Threshold (APCT) measured at the 6-month follow-up post-implant visit	6 Months
Secondary	Secondary Efficacy 2	Electrode Acoustic Pacing Capture Threshold Stability (APCT Stability) measured from pre-discharge through the 6-month follow-up post-implant visit	6 Months
Secondary	Secondary Efficacy 3	% Bi-ventricular pacing at 6 months	6 months
Secondary	Secondary Efficacy 4	EF responder analysis for = 5% absolute increase from baseline to 6 months.	6 months
Secondary	Secondary Efficacy 5	KCCQ responder analysis for = 5 points absolute increase from baseline to 6 months	6 months