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

Heart Failure Clinical Trial

— BIO|REDUCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839121
• Other study ID #: CR024
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: June 8, 2023

Study information

• Verified date: March 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Austria	Kepler University Clinic	Linz
Czechia	Fakultni Nemocnice Hradec Králové	Králová
Czechia	Fakultni Nemocnice Olomouc	Olomouc
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	RHÖN-KLINIKUM Campus Bad Neustadt	Bad Neustadt An Der Saale
Germany	Vivantes Humboldt-Klinikum	Berlin
Germany	Charitè University Clinic, Campus Benjamin Franklin	Berlin-Steglitz
Germany	Herzzentrum Dresden Univesity Clinic at Technical University Dresden	Dresden
Germany	Städtisches Klinikum Dresden, Friedrichstadt	Dresden
Germany	Evangelical Hospital Düsseldorf	Düsseldorf
Germany	Heinrich-Heine University Düsseldorf	Düsseldorf
Germany	University Clinic Erlangen	Erlangen
Germany	University Clinic Würzburg	Erlangen
Germany	Elisabeth-Krankenhaus Essen	Essen
Germany	KMG Clinic Güstrow	Güstrow
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 Ob Der Tauber
Hungary	Semmelweis Medical University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Czechia,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Documentation of patient characteristics and medication		through study completion, on average 12 months
Other	Assessment of patients benefit from CRT	Documentation of NYHA class	Baseline, 3, 6 and 12 months
Other	Documentation of LVEF	Left ventricular ejection fraction [%]	6 and 12 months (optional for PHD and 3 months)
Other	Documentation of LVESV	Left ventricular end-systolic volume [ml]	6 and 12 months (optional for PHD and 3 months)
Other	Documentation of LVEDV	Left ventricular end-diastolic volume [ml]	6 and 12 months (optional for PHD and 3 months)
Other	Documentation of atrial sensing amplitude		through study completion, on average 12 months
Other	Documentation of statistics of device pacing counters		through study completion, on average 12 months
Other	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
Other	Documentation of implantation data	e.g. implantation time, lead position	through study completion, on average 12 months
Other	Number of serious adverse events	Documentation of serious adverse events	through study completion, on average 12 months
Primary	Number of implantation of a right atrial lead after conclusion of the initial study device implantation		through study completion, on average 12 months
Secondary	Number of post-operative system revisions requiring an invasive re-intervention		through study completion, on average 12 months
Secondary	Number of lead complications requiring an invasive re-intervention		through study completion, on average 12 months
Secondary	Number of device or pocket infections requiring an invasive re-intervention		through study completion, on average 12 months