Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds

Completed · Not applicable

Conditions studied: Heart Failure, ICD, Chronotropic Incompetence

In brief

Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life. Patients are being asked to participate in this study if they have a history of heart failure and have or are scheduled to be implanted with a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting that works with the cardiovascular system to optimize their heart rate during physical activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer setting, which also is able to adjust the heart rate by movement sensors, when necessary. This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by BIOTRONIK, Inc. There will be approximately 15 participants in this trial.

Key facts

Study ID

NCT02693262

Run by

University of California, San Diego

People needed

12

Starts

2016-07-01

Expected to finish

2020-07-24

Last updated by the study team

2021-08-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with a BIOTRONIK CRT-D device (capable of CLS and accelerometer rate responsive pacing)
• Patients at least 18 years old
• Patients who have plausible symptoms of CI based on previous monitoring and clinical symptoms

You may not qualify if…

• Pregnant patients
• Patients who are unwilling/unable to provide informed consent
• Patients who are unable to complete study related procedures
• Current persistent atrial fibrillation

Where it is running

• Sulpizio Cardiovascular Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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