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.
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
Enrollment
100
Implant of left ventricular receiver-electrode and ultrasound transmitter.
Aalborg University Hospital
Aalborg, Denmark
Herzzentrum Brandenburg
Bernau, Germany
Cardiocentro Ticini
Lugano, Switzerland
Complications
Device and procedure related complications
Time frame: 24 hour perioperative, one month
Performance
Bi-ventricular capture on 12 lead EKG
Time frame: six months
Device Complications
Device and procedure related complications
Time frame: six months
Major Complications
All major complications
Time frame: six months
Complications
Device and procedure related complications
Time frame: annually to 5 years
Performance
Bi-ventricular capture on 12 lead EKG
Time frame: annually to 5 years
Evidence of Efficacy
Clinical composite score (All-cause mortality, HF hospitalizations, NYHA class, and patient global assessment)
Time frame: 6 months
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