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

NCT ID: NCT03839121

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-06-08

Brief Summary

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.

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

single arm: CRT-DX

Cardiac Resynchronization Therapy (CRT)

Intervention Type: DEVICE

Observation and documentation of CRT patients

Interventions

Cardiac Resynchronization Therapy (CRT)

Observation and documentation of CRT patients

Intervention Type: DEVICE

Eligibility Criteria

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 by appropriate routine method (e.g. 24 h holter electrocardiogram)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christof Kolb, Prof.

Role: PRINCIPAL_INVESTIGATOR

DHM, München

Locations

Kepler University Clinic

Linz, , Austria

Fakultni Nemocnice Hradec Králové

Králová, , Czechia

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Vivantes Humboldt-Klinikum

Berlin, , Germany

Herzzentrum Dresden Univesity Clinic at Technical University Dresden

Dresden, , Germany

Städtisches Klinikum Dresden, Friedrichstadt

Dresden, , Germany

Heinrich-Heine University Düsseldorf

Düsseldorf, , Germany

University Clinic Erlangen

Erlangen, , Germany

Elisabeth-Krankenhaus Essen

Essen, , Germany

Westpfalz-Klinikum

Kaiserslautern, , Germany

University Clinic SH Campus Kiel

Kiel, , Germany

Clinic St. Georg

Leipzig, , Germany

DHM

Munich, , Germany

Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss

Neuss, , Germany

Marien Hospital Papenburg Aschendorf

Papenburg, , Germany

Cardio Consil GmbH

Rostock, , Germany

Krankenhaus Rothenburg ob der Tauber

Rothenburg upon Tauber, , Germany

Charitè University Clinic, Campus Benjamin Franklin

Steglitz, , Germany

University Clinic Würzburg

Würzburg, , Germany

Semmelweis Medical University

Budapest, , Hungary

Countries

Austria; Czechia; Germany; Hungary

Other Identifiers

CR024

Identifier Type: -

Identifier Source: org_study_id