CompletedNot Applicable

Safety and Performance of Electrodes Implanted in the Left Ventricle

Czechia, Denmark39 participantsStarted 2013-07

Plain-language summary

The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure patients.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as "upgrades". Justifications for not using standard CRT must be documented in a CRF.
. Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as "untreated"

Exclusion criteria

. Inability to comply with the study follow-up or other study requirements
. History of chronic alcohol/drug abuse and currently using alcohol/drugs
. Non-ambulatory (or unstable) NYHA class 4
. Contraindication to heparin
. Contraindication to both chronic anticoagulants and antiplatelet agents
. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
. Thrombocytopenia (platelet count \<150,000)
. Contraindication to iodinated contrast agents

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with device-related adverse events as a measure of safety

Timeframe: 24 hour peri-operative and one month

Number of patients with procedure-related adverse events as a measure of safety

Timeframe: 24 hour perioperative and one month

Bi-ventricular pacing capture

Timeframe: one month

Trial details

NCT IDNCT01905670

SponsorEBR Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Heart Failure trials