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

NCT03839121 | Completed

• 1 other identifier: CR024
• Study Type: observational
• Target: 113
• Locations: 4 countries
• Sites: 21

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

Keywords

Heart Diseases; CRT-D

Outcome Measures

Primary Outcomes (1)

• Number of implantation of a right atrial lead after conclusion of the initial study device implantation

  through study completion, on average 12 months

Secondary Outcomes (3)

• 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 Outcomes (10)

• Documentation of patient characteristics and medication

  through study completion, on average 12 months

• Assessment of patients benefit from CRT

  Baseline, 3, 6 and 12 months

• Echocardiographic changes - LVEF

  Baseline, 6 and 12 months (optional at other visits)

Study Arms (1)

single arm: CRT-DX

Device: Cardiac Resynchronization Therapy (CRT)

Interventions

Cardiac Resynchronization Therapy (CRT) DEVICE

Observation and documentation of CRT patients

single arm: CRT-DX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 persistent or permanent atrial fibrillation (AF) and do not require right atrial (RA) lead implantation at study enrolment.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (21)

Kepler University Clinic

Linz, Austria

Location

Fakultni Nemocnice Hradec Králové

Králová, Czechia

Location

Fakultni Nemocnice Olomouc

Olomouc, Czechia

Location

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Vivantes Humboldt-Klinikum

Berlin, Germany

Location

Herzzentrum Dresden Univesity Clinic at Technical University Dresden

Dresden, Germany

Location

Städtisches Klinikum Dresden, Friedrichstadt

Dresden, Germany

Location

Heinrich-Heine University Düsseldorf

Düsseldorf, Germany

Location

University Clinic Erlangen

Erlangen, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, Germany

Location

Westpfalz-Klinikum

Kaiserslautern, Germany

Location

University Clinic SH Campus Kiel

Kiel, Germany

Location

Clinic St. Georg

Leipzig, Germany

Location

DHM

Munich, Germany

Location

Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss

Neuss, Germany

Location

Marien Hospital Papenburg Aschendorf

Papenburg, Germany

Location

Cardio Consil GmbH

Rostock, Germany

Location

Krankenhaus Rothenburg ob der Tauber

Rothenburg upon Tauber, Germany

Location

Charitè University Clinic, Campus Benjamin Franklin

Steglitz, Germany

Location

University Clinic Würzburg

Würzburg, Germany

Location

Semmelweis Medical University

Budapest, Hungary

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Christof Kolb, Prof.

  DHM, München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 15, 2019
• Study Start: April 1, 2019
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: April 9, 2025

Record last verified: 2022-03

Locations

CZ (2); HU (1); AU (1); DE (17)