Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)
|Heart Failure Ventricular Dysfunction Cardiomyopathy||Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy|
- Number of patients with device-related adverse events as a measure of safety [ Time Frame: 24 hour peri-operative and one month ]Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
- Number of patients with procedure-related adverse events as a measure of safety [ Time Frame: 24 hour perioperative and one month ]Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
- Bi-ventricular pacing capture [ Time Frame: one month ]Bi-ventricular pacing capture documented on 12-lead EKG
- Number of patients with device-related adverse events as a measure of safety [ Time Frame: 6 months ]Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
- Number of patients with serious adverse events as a measure of safety [ Time Frame: 6 months ]
- Left ventricular pacing capture [ Time Frame: 1, 3, and 6 months ]Left ventricular pacing capture documented on 12-lead EKG
- Bi-ventricular pacing capture [ Time Frame: 3 and 6 months ]Bi-ventricular pacing capture documented on 12-lead EKG
- Bi-ventricular pacing capture [ Time Frame: 1, 3, and 6 months ]Bi-ventricular pacing capture on 24 hour ambulatory monitoring
- Clinical composite score [ Time Frame: 6 months ]Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
- Change in echocardiographic indices [ Time Frame: 6 months ]change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
- Change in blood laboratory Brain Natriuretic Peptide [ Time Frame: 6 months ]change in NT-proBNP level
|Study Start Date:||February 2011|
|Study Completion Date:||October 2016|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Implant of the 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
Other Name: WiCS-LV system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294527
|Nouvelles Clinicques Nantaises|
|Bad Nauheim, Germany|
|Klinium Coburg gGmbH|
|Facharztzentrum Dresden-Neustadt GbR|
|Herzzentrum Leipzig GmbH|
|Leiden University Medical Centre|
|Isala Klinieken Zwolle|
|Principal Investigator:||Angelo Auricchio, MD||Fondazione Cardiocentro, Lugano CH|