WiCS-LV Post Market Surveillance Registry
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|ClinicalTrials.gov Identifier: NCT02610673|
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : July 25, 2018
This is an observational, prospective, non-randomized collection of defined clinical data under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.
Patients will be enrolled and followed according to standard of care for 5 years.
|Condition or disease||Intervention/treatment|
|Cardiac Resynchronization Therapy||Device: WiCS-LV System|
A clinical registry will be used to collect data from all implanted patients, at all follow-ups and across all implanting centers. Implant procedure will be according to the 'Instruction for Use' of the system and assessments and follow-ups according the best clinical practice.
Anonymized data will be collected on Case Report Forms (CRF) for each patient in the registry. These data will be collected at the time of implant and at scheduled patient in-clinic follow-ups of 1 week, 3 months, 6 months, and 1, 2,3,4,5 years post implant. Patients entering the registry will be given a Registry code suitable to uniquely identify the patient, the implanting center, and the responsible physician.
Data will be consolidated into a dataset by the sponsor for analysis purposes. The sponsor may request support from the center to review patient records in order to monitor the data in cases where the data appears incomplete or appears to be inaccurate.
The data set will be consolidated such that each implanting center may access its own data, or as mutually agreed between centers, aggregate data. Data may be used by centers for purposes of publication or other objectives of the center.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||WiCS-LV Post Market Surveillance Registry|
|Actual Study Start Date :||February 8, 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||November 2021|
- Device: WiCS-LV System
Implant of left ventricular receiver-electrode and ultrasound transmitter.Other Names:
- Wireless Cardiac Stimulation
- Wireless Stimulation on the Endocardium - WiSE System
- Complications [ Time Frame: 24 hour perioperative, one month ]Device and procedure related complications
- Performance [ Time Frame: six months ]Bi-ventricular capture on 12 lead EKG
- Device Complications [ Time Frame: six months ]Device and procedure related complications
- Major Complications [ Time Frame: six months ]All major complications
- Complications [ Time Frame: annually to 5 years ]Device and procedure related complications
- Performance [ Time Frame: annually to 5 years ]Bi-ventricular capture on 12 lead EKG
- Evidence of Efficacy [ Time Frame: 6 months ]Clinical composite score (All-cause mortality, HF hospitalizations, NYHA class, and patient global assessment)
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): NCT02610673
|Aalborg University Hospital|
|Aalborg, Denmark, 9100|