Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm

Study Overview
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Brief Summary
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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.

Official Title
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BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction

Conditions
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Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
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* Device: Cardiac Resynchronization Therapy (CRT)


Participation Criteria
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Eligibility Criteria
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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 atrial fibrillation. Patient has no atrioventricular (AV) block I or higher (PR interval more than 200 ms). 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 by appropriate routine method (e.g. 24 h holter electrocardiogram)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single arm: CRT-DX<br> | Device: Cardiac Resynchronization Therapy (CRT)<br>* Observation and documentation of CRT patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of implantation of a right atrial lead after conclusion of the initial study device implantation |  | through study completion, on average 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of post-operative system revisions requiring an invasive re-intervention |  | through study completion, on average 12 months | 
| Number of lead complications requiring an invasive re-intervention |  | through study completion, on average 12 months | 
| Number of device or pocket infections requiring an invasive re-intervention |  | through study completion, on average 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Diseases, CRT-D