Clinical trial NCT01905670: Safety and Performance of Electrodes Implanted in the Left Ventricle
Official title: Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Keywords: Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing
Lead sponsor: EBR Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure patients.

Detailed description: Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system.

Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.

Eligibility criteria: Inclusion Criteria:

Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these two categories:

1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as "upgrades". Justifications for not using standard CRT must be documented in a CRF.
2. Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as "untreated"

Exclusion Criteria:

1. Inability to comply with the study follow-up or other study requirements
2. History of chronic alcohol/drug abuse and currently using alcohol/drugs
3. Non-ambulatory (or unstable) NYHA class 4
4. Contraindication to heparin
5. Contraindication to both chronic anticoagulants and antiplatelet agents
6. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
7. Thrombocytopenia (platelet count \<150,000)
8. Contraindication to iodinated contrast agents
9. Intracardiac thrombus by transesophageal echocardiography
10. Age less than 18 years or greater than 75
11. Attempted IPG implant within 3 days
12. Life expectancy of less than 12 months
13. Chronic hemodialysis
14. Stage 4 or 5 renal dysfunction defined as GFR \<30
15. Grade 4 mitral valve regurgitation
16. Myocardial infarction within one month
17. Major cardiac surgery within one month
18. History of a pericardial effusion in prior procedures
19. Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable)
20. Non-cardiac implanted electrical stimulation therapy devices

Primary outcomes:
measure: Number of patients with device-related adverse events as a measure of safety
timeFrame: 24 hour peri-operative and one month
measure: Number of patients with procedure-related adverse events as a measure of safety
timeFrame: 24 hour perioperative and one month
measure: Bi-ventricular pacing capture
timeFrame: one month
Secondary outcomes:
measure: Number of patients with device-related adverse events as a measure of safety
timeFrame: 6 months
measure: Number of patients with serious adverse events as a measure of safety
timeFrame: 6 months
measure: Bi-ventricular pacing capture
timeFrame: 6 months
measure: Clinical composite score
timeFrame: 6 months
measure: Change in echocardiographic indices
timeFrame: 6 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
References:
citation: Reddy VY, Miller MA, Neuzil P, Sogaard P, Butter C, Seifert M, Delnoy PP, van Erven L, Schalji M, Boersma LVA, Riahi S. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129. doi: 10.1016/j.jacc.2017.02.059.