Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Condition: Heart Failure; ICD; Chronotropic Incompetence
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This study is a prospective, randomized, single-blind crossover study intended to enroll
      patients who are implanted or are scheduled to be implanted with a Biotronik CLS and
      accelerometer capable CRT-D device. Patients will serve as their own control group with
      regard to modes of rate-adaptive pacing. Patients with a previously implanted Biotronik CRT-D
      device with CLS-capability will be recruited from health care institutions in San Diego and
      all dedicated functional testing will be performed at the University of California, San Diego
      (UCSD). The goal enrollment target for analysis will be 15 patients, with up to 20 patients
      enrolled to allow for withdrawals.

      The purpose of this study is to evaluate whether changes to an implanted ICD can improve the
      functional status of patients with suspected chronotropic incompetence (CI). CI is a
      condition in which the heart rate is unable to adequately respond to meet the patient's
      physical demands, such as walking, climbing stairs, or doing household chores. CI is common
      in patients with cardiovascular disease, particularly in patients with heart failure. Common
      clinical management of patients with suspected CI is to activate an accelerometer setting in
      the cardiac resynchronization therapy with defibrillator (CRT-D) device. An accelerometer
      will adjust the heart rate to fit the physiological circumstances and needs of the patient
      based on patient movement only. BIOTRONIK is a company that has developed a novel technology
      included in the settings for CRT-D devices that offers CLS as an alternative to a standard
      accelerometer. CLS utilizes sensed electrical properties of the heart in order to assess what
      may be the best heart rate for both physical and mental demands. This study is designed to
      compare whether patients will benefit from CLS when compared with standard accelerometer
      technology.
    

Intervention name(s): CLS Mode on Biotronik CRT-D; Accelerometer Mode on Biotronik CRT-D
Intervention type(s): Device; Device
Intervention description(s): Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.; Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: defibrillator; heart failure; ICD; CRT-D; cardiac resynchronization therapy; rate response; CLS; closed-loop stimulation; accelerometer; chronotropic incompetence