Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | February 2016 |
| End Date: | March 2018 |
| Contact: | Kathryn Lewis, BS |
| Email: | kel139@ucsd.edu |
| Phone: | 858-657-5379 |
Rate Response With CLS Versus Accelerometer and Effect on Both Subjective Symptoms and Objective Outcomes in a Heart Failure Population Implanted With Cardiac Resynchronization With Defibrillator Device: The CLASS Trial
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant patients
- Patients who are unwilling/unable to provide informed consent
- Patients who are unable to complete study related procedures
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