Status:
COMPLETED
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
BIO\|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality. Howev...
Detailed Description
The magnitude of clinical and hemodynamic benefit of CRT varies significantly among its recipients. Many studies report that approximately one-third of the implanted population show no clinical improv...
Eligibility Criteria
Inclusion
- Indication for de novo implantation or upgrade to a CRT-D device
- Enrolled in BIO\|STREAM.HF but not yet implanted with or upgraded to CRT-D
- LVEF \< 35%
- QRS \> 120 ms
- NYHA II-IV
- Atrial heart rate during sinus rhythm at rest below 100 bpm
- Patient is able to understand the nature of the study and willing to provide written informed consent to this submodule
Exclusion
- Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- History of persistent/permanent AF
- History of complete AV-block
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04774523
Start Date
August 31 2021
End Date
July 31 2025
Last Update
September 18 2025
Active Locations (1)
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1
Dr Francisco Javier Garcia
Burgos, Castille and León, Spain, 09006