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The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.
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 |
|---|---|---|---|---|
| Wireless cardiac stimulator implant to pace the left ventricle for CRT | Device | 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 indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Auricchio, MD | Fondazione Cardiocentro, Lugano CH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nouvelles Clinicques Nantaises | Nantes | France | ||||
| Hospital Pontchaillou-CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24497573 | Derived | Auricchio A, Delnoy PP, Butter C, Brachmann J, Van Erven L, Spitzer S, Moccetti T, Seifert M, Markou T, Laszo K, Regoli F; Collaborative Study Group. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4. | |
| 23703364 |
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|
| 6 months |
| Left ventricular pacing capture | Left ventricular pacing capture documented on 12-lead EKG | 1, 3, and 6 months |
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | 3 and 6 months |
| Bi-ventricular pacing capture | Bi-ventricular pacing capture on 24 hour ambulatory monitoring | 1, 3, and 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 |
| Change in blood laboratory Brain Natriuretic Peptide | change in NT-proBNP level | 6 months |
| Rennes |
| France |
| Kerckhoff-Klinik | Bad Nauheim | Germany |
| Herzzentrum Brandenburg | Bernau | Germany |
| Klinium Coburg gGmbH | Coburg | Germany |
| Facharztzentrum Dresden-Neustadt GbR | Dresden | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | Germany |
| Leiden University Medical Centre | Leiden | Netherlands |
| Isala Klinieken Zwolle | Zwolle | Netherlands |
| Cardiocentro Ticini | Lugano | Switzerland |
| Derived |
| Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C; collaborative study group. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013 Aug;15(8):1191-7. doi: 10.1093/europace/eut124. Epub 2013 May 23. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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