Clinical trial NCT03839121: Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Keywords: Heart Diseases
CRT-D
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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)

Primary outcomes:
measure: Number of implantation of a right atrial lead after conclusion of the initial study device implantation
timeFrame: through study completion, on average 12 months
Secondary outcomes:
measure: Number of post-operative system revisions requiring an invasive re-intervention
timeFrame: through study completion, on average 12 months
measure: Number of lead complications requiring an invasive re-intervention
timeFrame: through study completion, on average 12 months
measure: Number of device or pocket infections requiring an invasive re-intervention
timeFrame: through study completion, on average 12 months
Other outcomes:
measure: Documentation of patient characteristics and medication
timeFrame: through study completion, on average 12 months
measure: Assessment of patients benefit from CRT
timeFrame: Baseline, 3, 6 and 12 months
measure: Echocardiographic changes - LVEF
timeFrame: Baseline, 6 and 12 months (optional at other visits)
measure: Echocardiographic changes - LVESV/LVEDV
timeFrame: Baseline, 6 and 12 months (optional at other visits)
measure: Echocardiographic changes - LVESD/LVEDD
timeFrame: Baseline, 6 and 12 months (optional at other visits)
measure: Echocardiographic changes - LAV
timeFrame: Baseline, 6 and 12 months (optional at other visits)
measure: Documentation of atrial sensing amplitude
timeFrame: through study completion, on average 12 months
measure: Documentation of programming of a non-AV-sequential pacing mode (e.g. VVI) except if justified by atrial fibrillation
timeFrame: through study completion, on average 12 months
measure: Documentation of implantation data
timeFrame: through study completion, on average 12 months
measure: Number of serious adverse events
timeFrame: through study completion, on average 12 months
Locations:
city: Linz
country: Austria
facility: Kepler University Clinic
city: Králová
country: Czechia
facility: Fakultni Nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Bad Neustadt An Der Saale
country: Germany
facility: RHÖN-KLINIKUM Campus Bad Neustadt
city: Berlin-Steglitz
country: Germany
facility: Charitè University Clinic, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Humboldt-Klinikum
city: Dresden
country: Germany
facility: Herzzentrum Dresden Univesity Clinic at Technical University Dresden
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden, Friedrichstadt
city: Düsseldorf
country: Germany
facility: Heinrich-Heine University Düsseldorf
city: Erlangen
country: Germany
facility: University Clinic Erlangen
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum
city: Kiel
country: Germany
facility: University Clinic SH Campus Kiel
city: Leipzig
country: Germany
facility: Clinic St. Georg
city: Munich
country: Germany
facility: DHM
city: Neuss
country: Germany
facility: Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss
city: Papenburg
country: Germany
facility: Marien Hospital Papenburg Aschendorf
city: Rostock
country: Germany
facility: Cardio Consil GmbH
city: Rothenburg Ob Der Tauber
country: Germany
facility: Krankenhaus Rothenburg ob der Tauber
city: Würzburg
country: Germany
facility: University Clinic Würzburg
city: Budapest
country: Hungary
facility: Semmelweis Medical University
Study officials:
affiliation: DHM, München
name: Christof Kolb, Prof.
role: PRINCIPAL_INVESTIGATOR
References: