Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronizatio

Not Applicable

Recruiting

• Conditions: Heart Failure; D006333

• Registration Number: JPRN-jRCTs032210268
• Lead Sponsor: Kato Ritsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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 based on pre-enrollment ECG.
- Patient is able to understand the nature of the study and willing to provide written informed
consent

Exclusion Criteria

- Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- History of persistent/permanent AF
- complete AV-block

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRT-responder rate at 12 months based on improvement in clinical composite score developed by Packer.

Secondary Outcome Measures

Name	Time	Method
1. Acute hemodynamic effect of AutoAdapt<br>2. Change in LVEF / LVEDD(V) / LVESD(V) between baseline and 12 month FU<br>3. Change in NYHA class through 12 months<br>4. Percentage of LV only pacing at 12 month FU<br>5. Unplanned hospitalization for worsening heart failure<br>6. Re-admission after first hospitalization for worsening heart failure<br>7. Adverse device effects related to the CRT AutoAdapt feature