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

NCT04774523 | Completed

• 1 other identifier: CR028
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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. However, additional clinical data on the short and mid-term improvement of CRT-D patients by the CRT AutoAdapt feature are needed.

Conditions

Heart Failure; Cardiac Arrhythmia; Left Ventricular Dysfunction

Keywords

CRT therapy; Heart Failure; AV optimization; Left Ventricular Ejection Fraction; AutoAdapt algorithm

Outcome Measures

Primary Outcomes (1)

• CRT-responder rate based on improvement in Clinical Composite Score developed by Packer at 12 month follow up.

  It will be use Packer Score to assess the clinical outcome in heart failure patients. It takes into account all possible dimensions of outcome, i.e. mortality, morbidity and quality of life and is based on the following data points: * Death (yes/no) * Any unplanned hospitalization for worsening heart failure (yes/no) * Change in NYHA class compared to baseline (improved/unchanged/worsened) * Patient's global assessment (PGA) compared to baseline (improved - three stages / unchanged / worsened - three stages) * Discontinuation of study protocol due to worsening heart failure, treatment failure or lacking therapeutic response (yes/no) At the end of the study, the outcome of each patient is classified as: * Worsened * Unchanged * Improved

  12 month Follow Up

Secondary Outcomes (7)

• Acute hemodynamic effect of AutoAdapt feature

  At pre-hospital discharge assessed up to 30 days since the implantation

• Change in LVEF

  12 month Follow Up

• Change in Left Ventricular End Diastolic and Systolic Diameter (LVED(S)D)

  12 month Follow Up

• Change in Left Ventricular End Diastolic and Systolic Volumes (LVED(S)V)

  12 month Follow Up

• Change in NYHA class

  12 month Follow Up

Study Arms (2)

Control group

ACTIVE COMPARATOR

This group will be made up of patients implanted with CRT-D devices without the CRT AutoAdapt feature, or with the CRT AutoAdapt feature deactivated.

Procedure: Echocardiography AV optimization; Procedure: Echocardiography; Other: Self Assessment Score

AutoAdapt group

EXPERIMENTAL

This group will be made up of patients implanted with CRT-D devices that have the CRT AutoAdapt feature available. It is mandatory that all patients within this group have the feature activated, independently of other characteristics.

Procedure: Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.; Procedure: Echocardiography; Other: Self Assessment Score

Interventions

Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature. PROCEDURE

Patients in the AutoAdapt group undergo the echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature. Three steps must be followed: 1. Standard AV programming: perform echo for AoVTI assessment. 2. Echo-optimized AV programming: perform standard echo-based AV-optimization (Ritter method or iterative method, according to routine at investigational site); measure AoVTI at optimized setting. 3. AutoAdapt optimized programming: The system allows different programming options for the parameter 'Adaptive AV reduction'. The nominal value is 0.7, but it can be modified to different values ranging from 0.5 to 0.9. The AoVTI shall be measured at standard setting of the "Adaptive Av reduction" parameter, 0.7.

AutoAdapt group

Echocardiography AV optimization PROCEDURE

Patient in the control group undergo the routine echo-based AV-optimization that is usually performed at the investigational site (Ritter method or iterative method). Performance of an additional VV-delay optimization is left to the investigator discretion

Control group

Echocardiography PROCEDURE

Echocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V)

AutoAdapt group; Control group

Self Assessment Score OTHER

Patient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score

AutoAdapt group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (1)

Dr Francisco Javier Garcia

Burgos, Castille and León, 09006, Spain

Location

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Study Officials

• Francisco Javier García Fernandez, Physician

  Hospital Universitario de Burgos, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be two arms with the same study flow chart along the study.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 1, 2021
• Study Start: August 31, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

ES (1)