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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2022

Interventions

  • Device: Cardiac Resynchronization Therapy (CRT)
    • Observation and documentation of CRT patients

Arms, Groups and Cohorts

  • single arm: CRT-DX

Clinical Trial Outcome Measures

Primary Measures

  • Number of implantation of a right atrial lead after conclusion of the initial study device implantation
    • Time Frame: through study completion, on average 12 months

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotronik SE & Co. KG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dietmar Bänsch, Prof., Principal Investigator, KMG Kliniken, Güstrow
    • Christof Kolb, Prof., Principal Investigator, DHM, München
  • Overall Contact(s)
    • Angelika Felk, Dr., +49 (0) 151 16321781, bioreduce.study@biotronik.com

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