NCT02610673

WiCS-LV Post Market Surveillance Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: EBR Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	WiCS-LV System	Implant of left ventricular receiver-electrode and ultrasound transmitter.

Timeline

• Start date: 2016-02-08
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2015-11-20
• Last updated: 2025-03-21

Locations

3 sites across 3 countries: Denmark, Germany, Switzerland