Heart FailureBIO|AdaptNCT04774523
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
A study testing Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization and Echocardiography in people with Heart Failure and Cardiac Arrhythmia, run by Biotronik SE & Co. KG at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Arrhythmia, Left Ventricular Dysfunction
- What is being tested?
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization and Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- History of persistent/permanent AF
- History of complete AV-block
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 improvement at follow-ups. There are many clinical factors that are associated with the CRT response and the grade of benefit, such as type of cardiomyopathy, severity of electrical conduction abnormalities, dyssynchrony, and scar burden. In addition, there are device-related factors such as lead location, insufficient ventricular pacing percentage (%V), and suboptimal atrial-ventricular (AV) and ventricle- ventricle (VV) timing.
The main finding in such CRT non-responders is a suboptimal AV-timing (47%). The optimization of AV and VV intervals during biventricular (BiV) pacing is an option to maximize the positive effects of CRT, by taking advantage of the full atrial contraction for optimal filling of the ventricles. Optimization is usually accomplished by using echocardiography or other methods. However, such methods are time consuming for the hospitals and may not provide a benefit for every patient.
The most common pacing mode for CRT therapy is BiV pacing, but many acute and chronic randomized clinical studies have demonstrated that left-ventricular (LV) pacing can be at least as effective as BiV pacing. In patients with sinus rhythm and normal atrioventricular (AV) conduction, pacing the left ventricle only with an appropriate AV interval can result in an even superior LV and right ventricular (RV) function compared with standard BiV pacing. LV pacing has been proposed as an alternative approach to apply cardiac resynchronization as it has been shown that LV pacing induces short-term hemodynamic benefits compared to BiV pacing.
Different algorithms have been developed by different manufactures to provide continuous automatic CRT optimization, allowing a more physiologic ventricular activation and greater device longevity in patients with normal AV conduction due to the reduction of unnecessary RV pacing. Studies with the Medtronic Adaptive cardiac resynchronization therapy (aCRT) algorithm, that provides automatic ambulatory selection between synchronized LV or BiV pacing with dynamic optimization of atrioventricular and interventricular delays, have shown that the algorithm is safe and as effective as BiV pacing with comprehensive echocardiographic optimization.
The CRT AutoAdapt feature by BIOTRONIK optimizes the CRT therapy settings of the device automatically and continuously. This algorithm adjusts the AV delay and sets the ventricular pacing configuration to BiV or LV. The settings are based on intracardiac conduction times, which are measured every 60 seconds to select the optimal configuration.
The objective of this study is to show non-inferiority of this feature compared to standard echo-based optimization with regard to clinical benefit.
- Being tested
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization, Echocardiography, Self Assessment Score
- Keywords
- CRT therapy, Heart Failure, AV optimization, Left Ventricular Ejection Fraction, AutoAdapt algorithm
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.Procedure or surgery
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:
- Standard AV programming: perform echo for AoVTI assessment.
- 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.
- 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.
Echocardiography AV optimizationProcedure or surgery
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
EchocardiographyProcedure or surgery
Echocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V)
Self Assessment ScoreOther
Patient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.; Procedure: Echocardiography; Other: Self Assessment Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month Follow Up
Secondary outcomes (7)
Acute hemodynamic effect of AutoAdapt feature
The acute hemodynamic response to different parameter settings will be assessed by measuring the aortic velocity time integral (AoVTI) via echocardiography.
Measured: At pre-hospital discharge assessed up to 30 days since the implantation
Change in LVEF
The intra-individual change in LVEF from baseline to 12 month FU will be assessed by echocardiography as a measure of improvement in cardiac function and compared between patient groups.
Measured: 12 month Follow Up
Change in Left Ventricular End Diastolic and Systolic Diameter (LVED(S)D)
The intra-individual change in LVED(S)D from baseline to 12 month FU will be assessed by echocardiography as a measure of ventricular reverse remodeling and compared between patient groups.
Measured: 12 month Follow Up
Change in Left Ventricular End Diastolic and Systolic Volumes (LVED(S)V)
The intra-individual change in LVED(S)V from baseline to 12 month FU will be assessed by echocardiography as a measure of ventricular reverse remodeling and compared between patient groups.
Measured: 12 month Follow Up
Change in NYHA class
The intra-individual change in the NYHA classification from baseline to 12 months will be assessed as a measure of overall functional improvement and compared between patient groups.
Measured: 12 month Follow Up
Percentage of LV only pacing
The percentage of LV only pacing based on device statistics will be assessed at the 12 months FU and compared between patient groups to assess the potential to reduce battery consumption by the AutoAdapt feature.
Measured: 12 month Follow Up
Adverse device effects related to the CRT AutoAdapt feature
Evaluation of all reported adverse device effects for a possible relation with the CRT AutoAdapt feature
Measured: 12 month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start31 Aug 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be two arms with the same study flow chart along the study.
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Javier García Fernandez, Physician, Principal investigator, Hospital Universitario de Burgos, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774523
- Sponsor's protocol ID
- CR028
- Acronym
- BIO|Adapt
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
- ClinicalTrials.gov ID
- NCT04774523
- Acronym / sponsor ID
- BIO|Adapt / CR028
- Keywords
- CRT therapy, Heart Failure, AV optimization, Left Ventricular Ejection Fraction, AutoAdapt algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 improvement at follow-ups. There are many clinical factors that are associated with the CRT response and the grade of benefit, such as type of cardiomyopathy, severity of electrical conduction abnormalities, dyssynchrony, and scar burden. In addition, there are device-related factors such as lead location, insufficient ventricular pacing percentage (%V), and suboptimal atrial-ventricular (AV) and ventricle- ventricle (VV) timing.
The main finding in such CRT non-responders is a suboptimal AV-timing (47%). The optimization of AV and VV intervals during biventricular (BiV) pacing is an option to maximize the positive effects of CRT, by taking advantage of the full atrial contraction for optimal filling of the ventricles. Optimization is usually accomplished by using echocardiography or other methods. However, such methods are time consuming for the hospitals and may not provide a benefit for every patient.
The most common pacing mode for CRT therapy is BiV pacing, but many acute and chronic randomized clinical studies have demonstrated that left-ventricular (LV) pacing can be at least as effective as BiV pacing. In patients with sinus rhythm and normal atrioventricular (AV) conduction, pacing the left ventricle only with an appropriate AV interval can result in an even superior LV and right ventricular (RV) function compared with standard BiV pacing. LV pacing has been proposed as an alternative approach to apply cardiac resynchronization as it has been shown that LV pacing induces short-term hemodynamic benefits compared to BiV pacing.
Different algorithms have been developed by different manufactures to provide continuous automatic CRT optimization, allowing a more physiologic ventricular activation and greater device longevity in patients with normal AV conduction due to the reduction of unnecessary RV pacing. Studies with the Medtronic Adaptive cardiac resynchronization therapy (aCRT) algorithm, that provides automatic ambulatory selection between synchronized LV or BiV pacing with dynamic optimization of atrioventricular and interventricular delays, have shown that the algorithm is safe and as effective as BiV pacing with comprehensive echocardiographic optimization.
The CRT AutoAdapt feature by BIOTRONIK optimizes the CRT therapy settings of the device automatically and continuously. This algorithm adjusts the AV delay and sets the ventricular pacing configuration to BiV or LV. The settings are based on intracardiac conduction times, which are measured every 60 seconds to select the optimal configuration.
The objective of this study is to show non-inferiority of this feature compared to standard echo-based optimization with regard to clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two arms with the same study flow chart along the study.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Echocardiography AV optimization, Procedure: Echocardiography, Other: Self Assessment ScoreThis group will be made up of patients implanted with CRT-D devices without the CRT AutoAdapt feature, or with the CRT AutoAdapt feature deactivated. |
| AutoAdapt group | Experimental | Procedure: Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Procedure: Echocardiography, Other: Self Assessment ScoreThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- History of persistent/permanent AF
- History of complete AV-block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature.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. | Procedure or surgery | AutoAdapt group |
| Echocardiography AV optimizationPatient 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 | Procedure or surgery | Control group |
| EchocardiographyEchocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V) | Procedure or surgery | AutoAdapt group, Control group |
| Self Assessment ScorePatient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score | Other | AutoAdapt group, Control group |
Primary outcome
CRT-responder rate based on improvement in Clinical Composite Score developed by Packer at 12 month follow up.
Time frame: 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
7 secondary outcomes
Acute hemodynamic effect of AutoAdapt feature
Time frame: At pre-hospital discharge assessed up to 30 days since the implantation
Change in LVEF
Time frame: 12 month Follow Up
Change in Left Ventricular End Diastolic and Systolic Diameter (LVED(S)D)
Time frame: 12 month Follow Up
Change in Left Ventricular End Diastolic and Systolic Volumes (LVED(S)V)
Time frame: 12 month Follow Up
Change in NYHA class
Time frame: 12 month Follow Up
Percentage of LV only pacing
Time frame: 12 month Follow Up
Adverse device effects related to the CRT AutoAdapt feature
Time frame: 12 month Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Javier García Fernandez, Physician principal investigator
Hospital Universitario de Burgos, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization and Echocardiography in people with Heart Failure and Cardiac Arrhythmia, run by Biotronik SE & Co. KG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT-responder rate based on improvement in Clinical Composite Score developed by Packer at 12 month follow up. (time frame: 12 month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.