Status:
COMPLETED
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03839121
Start Date
April 1 2019
End Date
June 8 2023
Last Update
April 9 2025
Active Locations (21)
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1
Kepler University Clinic
Linz, Austria
2
Fakultni Nemocnice Hradec Králové
Králová, Czechia
3
Fakultni Nemocnice Olomouc
Olomouc, Czechia
4
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany