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Search / Trial NCT04774523

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

Launched by BIOTRONIK SE & CO. KG · Feb 24, 2021

Trial Information

Current as of May 08, 2025

Recruiting

Keywords

Crt Therapy Heart Failure Av Optimization Left Ventricular Ejection Fraction Auto Adapt Algorithm

ClinConnect Summary

The BIO|Adapt study is looking at a new feature called the AutoAdapt Algorithm, which helps improve heart function in patients with heart failure and related conditions. This feature automatically adjusts the timing of heart pacing to better fit the patient's needs. The study aims to gather more information about how this technology can help patients feel better and improve their heart health over time.

To be eligible for the study, participants must be between the ages of 65 and 74, have a specific heart condition that requires a special device called a CRT-D (Cardiac Resynchronization Therapy Defibrillator), and have a weakened heart function (measured by a score called LVEF). They should not have had certain types of heart problems in the past, like permanent atrial fibrillation. If you join the study, you'll work closely with healthcare professionals who will monitor your heart health and help assess how well this new feature works for you. Your participation could contribute to important research that benefits many others with similar heart issues.

Gender

ALL

Eligibility criteria

  • 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

About Biotronik Se & Co. Kg

Biotronik SE & Co. KG is a global leader in the development of innovative medical technology, specializing in cardiovascular and endovascular solutions. With a strong commitment to enhancing patient outcomes, the company focuses on advanced therapies and devices, including implantable cardioverter-defibrillators, cardiac resynchronization therapy, and vascular interventions. Biotronik's rigorous research and development initiatives, coupled with its dedication to clinical excellence, position the company at the forefront of medical advancement, striving to improve quality of life for patients worldwide. Through strategic partnerships and a robust clinical trial portfolio, Biotronik continues to drive innovation and set new standards in healthcare.

Locations

Burgos, Castilla Y Leon, Spain

Patients applied

0 patients applied

Trial Officials

Francisco Javier García Fernandez, Physician

Principal Investigator

Hospital Universitario de Burgos, Spain

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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