Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm (BIO|REDUCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy (CRT)

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Kepler University Clinic
• Czechia
  • Králová, Czechia
    • Fakultní nemocnice Hradec Králové
  • Olomouc, Czechia
    • Fakultni nemocnice Olomouc
• Germany
  • Bad Berka, Germany
    • Zentralklinik Bad Berka
  • Bad Neustadt An Der Saale, Germany
    • Rhön-Klinikum Campus Bad Neustadt
  • Berlin, Germany
    • Vivantes Humboldt-Klinikum
  • Berlin-Steglitz, Germany
    • Charitè University Clinic, Campus Benjamin Franklin
  • Dresden, Germany
    • Herzzentrum Dresden Univesity Clinic at Technical University Dresden
  • Dresden, Germany
    • Städtisches Klinikum Dresden, Friedrichstadt
  • Düsseldorf, Germany
    • Evangelical Hospital Düsseldorf
  • Düsseldorf, Germany
    • Heinrich-Heine University Düsseldorf
  • Erlangen, Germany
    • University Clinic Erlangen
  • Erlangen, Germany
    • University Clinic Würzburg
  • Essen, Germany
    • Elisabeth-Krankenhaus Essen
  • Güstrow, Germany
    • KMG Clinic Güstrow
  • Kaiserslautern, Germany
    • Westpfalz-Klinikum
  • Kiel, Germany
    • University Clinic SH Campus Kiel
  • Leipzig, Germany
    • Clinic St. Georg
  • Munich, Germany
    • DHM
  • Neuss, Germany
    • Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss
  • Papenburg, Germany
    • Marien Hospital Papenburg Aschendorf
  • Rostock, Germany
    • Cardio Consil GmbH
  • Rothenburg Ob Der Tauber, Germany
    • Krankenhaus Rothenburg ob der Tauber
• Hungary
  • Budapest, Hungary
    • Semmelweis Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication according to the current guidelines, who are in sinus rhythm without history of atrial fibrillation (AF) and do not require right atrial (RA) lead implantation at study enrolment.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single arm: CRT-DX	Device: Cardiac Resynchronization Therapy (CRT); Observation and documentation of CRT patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation of patient characteristics and medication		through study completion, on average 12 months
Assessment of patients benefit from CRT	Documentation of NYHA class	Baseline, 3, 6 and 12 months
Documentation of LVEF	Left ventricular ejection fraction [%]	6 and 12 months (optional for PHD and 3 months)
Documentation of LVESV	Left ventricular end-systolic volume [ml]	6 and 12 months (optional for PHD and 3 months)
Documentation of LVEDV	Left ventricular end-diastolic volume [ml]	6 and 12 months (optional for PHD and 3 months)
Documentation of atrial sensing amplitude		through study completion, on average 12 months
Documentation of statistics of device pacing counters		through study completion, on average 12 months
Documentation of programming of a non-AV-sequential pacing mode (e.g. VVI) except if justified by atrial fibrillation		through study completion, on average 12 months
Documentation of implantation data	e.g. implantation time, lead position	through study completion, on average 12 months
Number of serious adverse events	Documentation of serious adverse events	through study completion, on average 12 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Dietmar Bänsch, Prof., KMG Kliniken, Güstrow; Principal Investigator: Christof Kolb, Prof., DHM, München

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Heart Diseases; CRT-D
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No