Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02922036




Registration number
NCT02922036
Ethics application status
Date submitted
27/09/2016
Date registered
3/10/2016
Date last updated
4/03/2024

Titles & IDs
Public title
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Scientific title
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
Secondary ID [1] 0 0
CSP-03035
Universal Trial Number (UTN)
Trial acronym
SOLVE-CRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WiSE System

Experimental: Treatment - WiSE System therapy ON with Guideline Directed Medical Therapy


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Primary Efficacy 1
Timepoint [2] 0 0
6 Months
Secondary outcome [1] 0 0
Secondary Efficacy 1
Timepoint [1] 0 0
6 Months
Secondary outcome [2] 0 0
Secondary Efficacy 2
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Secondary Efficacy 3
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Secondary Efficacy 4
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Secondary Efficacy 5
Timepoint [5] 0 0
6 months

Eligibility
Key inclusion criteria
Inclusion/
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
CanberraNSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Monash Heart - Clayton
Recruitment hospital [8] 0 0
Royal Melbourne Hospital / Royal Hobart Hospital - Parkville
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [10] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
- Wahroonga
Recruitment postcode(s) [5] 0 0
- Chermside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment postcode(s) [9] 0 0
6150 - Perth
Recruitment postcode(s) [10] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
France
State/province [25] 0 0
Grenoble
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
Germany
State/province [28] 0 0
Bernau
Country [29] 0 0
Germany
State/province [29] 0 0
Erlangen
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Italy
State/province [31] 0 0
Bologna
Country [32] 0 0
Italy
State/province [32] 0 0
Monza
Country [33] 0 0
Netherlands
State/province [33] 0 0
Zwolle
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Liverpool
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Middlesbrough
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EBR Systems, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02922036
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jagmeet Singh, MD, PhD
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries