Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)
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|ClinicalTrials.gov Identifier: NCT01294527|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Ventricular Dysfunction Cardiomyopathy||Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||October 2016|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|