Other Clinical Trial - WiCS-LV Post Market Surveillance Registry

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cardiac Resynchronization Therapy

Clinical Trial Details

NCT number	NCT02610673
Study type	Observational [Patient Registry]
Source	EBR Systems, Inc.
Contact
Status	Active, not recruiting
Phase
Start date	February 8, 2016
Completion date	August 2025

View Details

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