The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO\|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
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:
* Patient is able to understand the nature of study and has provided written informed consent.
* Patient is willing and able to perform all follow up visits at the study site.
* Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
* CRT-D is indicated according to the current ESC guidelines.
* De novo implantation with no pre-existing defibrillator or pacemaker system
* Patient is in sinus rhythm without history of persistent or permanent atrial fibrillation.
* Patient has no atrioventricular (AV) block II or III.
* Patient has no evidence of impaired sinus node function.
* Patient has no need for atrial stimulation, has a resting heart rate (HR) \> 40 b.p.m and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment
* NYHA class II or III
* Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment
Exclusion Criteria:
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in an interventional clinical investigation.
* Life-expectancy is less than 1 year.
* Patient has tachycardia-bradycardia syndrome
* Any standard contraindication for CRT-D
* Frequent premature ventricular contractions (PVC rate \> 5 %/h) examined within 3 months prior to enrollment…
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
Number of implantation of a right atrial lead after conclusion of the initial study device implantation
Timeframe: through study completion, on average 12 months