BIO|REDUCE: Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| single arm: CRT-DX
|
Device: Cardiac Resynchronization Therapy (CRT)
Observation and documentation of CRT patients
|
Outcome Measures
Primary Outcome Measures
- Number of implantation of a right atrial lead after conclusion of the initial study device implantation [through study completion, on average 12 months]
Secondary Outcome Measures
- 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 Outcome Measures
- 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]
Documentation of NYHA class
- Documentation of LVEF [6 and 12 months (optional for PHD and 3 months)]
Left ventricular ejection fraction [%]
- Documentation of LVESV [6 and 12 months (optional for PHD and 3 months)]
Left ventricular end-systolic volume [ml]
- Documentation of LVEDV [6 and 12 months (optional for PHD and 3 months)]
Left ventricular end-diastolic volume [ml]
- Documentation of atrial sensing amplitude [through study completion, on average 12 months]
- Documentation of statistics of device pacing counters [through study completion, on average 12 months]
- 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]
- Documentation of implantation data [through study completion, on average 12 months]
e.g. implantation time, lead position
- Number of serious adverse events [through study completion, on average 12 months]
Documentation of serious adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is able to understand the nature of study and has provided written informed consent.
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Patient is willing and able to perform all follow up visits at the study site.
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Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
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CRT-D is indicated according to the current ESC guidelines.
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De novo implantation with no pre-existing defibrillator or pacemaker system
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Patient is in sinus rhythm without history of atrial fibrillation.
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Patient has no atrioventricular (AV) block I or higher (PR interval more than 200 ms).
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Patient has no evidence of impaired sinus node function.
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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
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NYHA class II or III
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Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment
Exclusion Criteria:
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Patient is pregnant or breast feeding.
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Patient is less than 18 years old.
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Patient is participating in an interventional clinical investigation.
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Life-expectancy is less than 1 year.
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Patient has tachycardia-bradycardia syndrome
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Any standard contraindication for CRT-D
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kepler University Clinic | Linz | Austria | ||
| 2 | Fakultni Nemocnice Hradec Králové | Králová | Czechia | ||
| 3 | Fakultni Nemocnice Olomouc | Olomouc | Czechia | ||
| 4 | Zentralklinik Bad Berka | Bad Berka | Germany | ||
| 5 | Charitè University Clinic, Campus Benjamin Franklin | Berlin-Steglitz | Germany | ||
| 6 | Herzzentrum Dresden Univesity Clinic at Technical University Dresden | Dresden | Germany | ||
| 7 | Städtisches Klinikum Dresden, Friedrichstadt | Dresden | Germany | ||
| 8 | Evangelical Hospital Düsseldorf | Düsseldorf | Germany | ||
| 9 | University Clinic Erlangen | Erlangen | Germany | ||
| 10 | University Clinic Würzburg | Erlangen | Germany | ||
| 11 | KMG Clinic Güstrow | Güstrow | Germany | ||
| 12 | Westpfalz-Klinikum | Kaiserslautern | Germany | ||
| 13 | University Clinic SH Campus Kiel | Kiel | Germany | ||
| 14 | Clinic St. Georg | Leipzig | Germany | ||
| 15 | DHM | Munich | Germany | ||
| 16 | Marien Hospital Papenburg Aschendorf | Papenburg | Germany | ||
| 17 | Cardio Consil GmbH | Rostock | Germany | ||
| 18 | Semmelweis Medical University | Budapest | Hungary |
Sponsors and Collaborators
- Biotronik SE & Co. KG
Investigators
- Principal Investigator: Dietmar Bänsch, Prof., KMG Kliniken, Güstrow
- Principal Investigator: Christof Kolb, Prof., DHM, München
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR024