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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02922036
Ethics application status
Date submitted
27/09/2016
Date registered
3/10/2016

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
NA
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
NA
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
1/06/2025
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
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Alabama
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California
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Grenoble
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France
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Paris
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France
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Rennes
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Bernau
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Erlangen
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Hamburg
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Bologna
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Monza
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Zwolle
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Liverpool
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London
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Manchester
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Middlesbrough
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United Kingdom
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Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02922036