Triple-site Biventricular Stimulation in the Optimization of CRT (NCT02350842) | Clinical Trial Compass
CompletedNot Applicable
Triple-site Biventricular Stimulation in the Optimization of CRT
France, Germany, Italy30 participantsStarted 2015-07
Plain-language summary
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.
Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.
Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.
Who can participate
Age range
18 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:
* Age \> 18 years
* Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
* Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
* Left ventricular ejection fraction (LVEF) ≤ 35%
* Intrinsic QRS duration ≥ 140 msec
* Non-typical left bundle branch block (LBBB) morphology on 12-lead surface ECG
* Signed and dated informed consent
Exclusion Criteria:
* Typical LBBB according to Strauss criteria
* Unstable heart failure
* Permanent or long-lasting persistent Atrial Fibrillation
* Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
* Conventional pacemaker indication
* Previous implant with a pacemaker or an Implantable Cardioverter-Defibrillator (ICD)
* Renal Failure (Glomerular filtration rate (GFR) \< 30 ml/min/1.73m2)
* Pregnant women
* Already included in another clinical study that could confound the results of this study
* Life expectancy \< 12 months
* Mechanical heart valve or indication for valve repair or replacement
* Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months)
* Heart transplant
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
1
TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.