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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-04-010803 | Other Identifier | EUDAMED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant | Experimental | Implant of the WiCS-LV system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WiCS-LV system | Device | Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with device-related adverse events as a measure of safety | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. | 24 hour peri-operative and one month |
| Number of patients with procedure-related adverse events as a measure of safety | Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure. | 24 hour perioperative and one month |
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with device-related adverse events as a measure of safety | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. | 6 months |
| Number of patients with serious adverse events as a measure of safety |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 150 30 | Czechia | |||
| Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28449772 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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|
| 6 months |
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | 6 months |
| Clinical composite score | Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment | 6 months |
| Change in echocardiographic indices | change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction | 6 months |
| Aalborg |
| 9100 |
| Denmark |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |