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

JRCT ID: jRCTs032210268

Registered date:23/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 31/08/2021
• Target sample size: 350
• Countries of recruitment: Spain,Japan,Portugal,Japan,Australia,Japan,Czech Republic,Japan,Poland,Japan,South Africa,Japan,Germany,Japan
• Study type: Interventional

Intervention(s)

The group allocation will be determined by the activation or not of the algorithm from medical criteria.
For AutoAdapt Group: The assessment of the acute hemodynamic effect of AutoAdapt must be performed in PHD Follow-Up. The final device programming has AutoAdapt feature ON as mandatory setting, or AV Adapt in those cases where the investigator sees a contraindication for only LV pacing in this time.

The 12 month FU (plus or minus 30 days) after implantation shall be scheduled in-office at the clinic. The following data shall be collected:
- Patient self-assessment
- Echocardiography parameters (LVEF/LVESD(V)/LVEDD(V))
- Device programming settings to verify the correct programming of the CRT AutoAdapt algorithm with respect to the group assignment in the study.

Outcome(s)

• Primary Outcome: CRT-responder rate at 12 months based on improvement in clinical composite score developed by Packer.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Kato Ritsushi
• Secondary Sponsor: BIOTRONIK JAPAN. INC.
• Secondary ID(s): NCT04774523