- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774523
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization (BIO|Adapt)
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paloma Quesada
- Phone Number: 0034 917 994 670
- Email: paloma.quesada@biotronik.com
Study Contact Backup
- Name: Angel Madrid
- Phone Number: 0034 917 994 670
- Email: angel.madrid@biotronik.com
Study Locations
-
-
Castilla Y Leon
-
Burgos, Castilla Y Leon, Spain, 09006
- Recruiting
- Dr Francisco Javier Garcia
-
Contact:
- Paloma Quesada
- Phone Number: +34608757231
- Email: paloma.quesada@biotronik.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Patient is able to understand the nature of the study and willing to provide written informed consent to this submodule
Exclusion Criteria:
- Planned implantation or previous implantation with a BIOTRONIK DX ICD lead
- History of persistent/permanent AF
- History of complete AV-block
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
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.
|
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
Echocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V)
Patient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score
|
Experimental: AutoAdapt group
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.
|
Echocardiography must be performed at baseline and 12 month Follow Up to collect the LVEF/LVESD(V)/LVEDD(V)
Patient must complete the self assessment score at 6 and 12 month Follow Up, that will be use for the Packer Clinical Composite Score
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
At the end of the study, the outcome of each patient is classified as:
|
12 month Follow Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute hemodynamic effect of AutoAdapt feature
Time Frame: At pre-hospital discharge assessed up to 30 days since the implantation
|
The acute hemodynamic response to different parameter settings will be assessed by measuring the aortic velocity time integral (AoVTI) via echocardiography.
|
At pre-hospital discharge assessed up to 30 days since the implantation
|
Change in LVEF
Time Frame: 12 month Follow Up
|
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.
|
12 month Follow Up
|
Change in Left Ventricular End Diastolic and Systolic Diameter (LVED(S)D)
Time Frame: 12 month Follow Up
|
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.
|
12 month Follow Up
|
Change in Left Ventricular End Diastolic and Systolic Volumes (LVED(S)V)
Time Frame: 12 month Follow Up
|
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.
|
12 month Follow Up
|
Change in NYHA class
Time Frame: 12 month Follow Up
|
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.
|
12 month Follow Up
|
Percentage of LV only pacing
Time Frame: 12 month Follow Up
|
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.
|
12 month Follow Up
|
Adverse device effects related to the CRT AutoAdapt feature
Time Frame: 12 month Follow Up
|
Evaluation of all reported adverse device effects for a possible relation with the CRT AutoAdapt feature
|
12 month Follow Up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francisco Javier García Fernandez, Physician, Hospital Universitario de Burgos, Spain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted
Clinical Trials on Echocardiography AV optimization
-
University Hospital, Gentofte, CopenhagenRigshospitalet, Denmark; Lund University HospitalUnknownHeart Failure | Ischemic CardiomyopathyDenmark, Sweden
-
Jessa HospitalCompletedQuality of Life | Pacemaker Ddd Permanent | Atrial DysfunctionBelgium
-
MicroPort CRMSorin CRMUnknownHeart Failure (NYHA Class III and Ambulatory IV)United States
-
Barry LondonTerminatedHeart Failure | Right Bundle-Branch BlockUnited States
-
University Hospital Schleswig-HolsteinCompletedPostoperative Complications | Hemodynamic Instability | Ultrasound ImagingGermany
-
MicroPort CRMCompleted
-
MicroPort CRMSorin CRMUnknownHeart Failure NYHA Class III and Ambulatory IVUnited States, Spain, United Kingdom, Germany, Italy, Australia, Netherlands, Portugal, France, Austria, Switzerland, Slovenia
-
Northwestern UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia With Suspected Alzheimer's DiseaseUnited States
-
Fondation Ophtalmologique Adolphe de RothschildTerminatedOcclusion or Malformation of a Cerebral VesselFrance