NL-OMON55596
Recruiting
N/A
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients - SOLVE CRT
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cardiac failure
- Sponsor
- EBR Systems, Inc.
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\) and EF criteria minimum on all classes):
- •a. Class I: NYHA II, III, IV, EF \<\= 35%, LBBB, QRS\>\=150ms
- •b. Class IIa (1\): NYHA II, III, IV, EF\<\=35%, LBBB, QRS\>\=130 to \<150ms
- •c. Class IIa (2\): NYHA II, III, IV, EF\<\=35%, non\-LBBB, QRS\>\=150ms
- •2\. Non\-responder\*: 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 remailing clinically
Exclusion Criteria
- •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 must be excluded
- •6\. Patients with planned or expected lithotripsy treatment post\-implant
- •7\. Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful
- •co\-implant
- •within the prior 30 days
Outcomes
Primary Outcomes
Not specified
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