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

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT02693262
Collaborator
Biotronik, Inc. (Industry)
12
Enrollment
1
Location
2
Arms
48.8
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: CLS Mode on Biotronik CRT-D
  • Device: Accelerometer Mode on Biotronik CRT-D
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Jul 24, 2020
Actual Study Completion Date :
Jul 24, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: CLS Mode on Biotronik CRT-D

All 15 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.

Device: CLS Mode on Biotronik CRT-D
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.

Active Comparator: Accelerometer Mode on Biotronik CRT-D

All 15 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.

Device: Accelerometer Mode on Biotronik CRT-D
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.

Outcome Measures

Primary Outcome Measures

  1. Six-minute Walk Distance (6MWD) Test [Measured on day 14 and day 21.]

    Cardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period.

  2. RAND-36 Questionnaire [Performed on day 14 and day 21.]

    Quality of life of subjects was measured by the RAND-36 which is a generic 36-item questionnaire that measures eight health-related domains stratified by physical health (physical functioning, role limitations due to physical health, pain, and general health) and emotional health (vitality, role limitations due to emotional problems, social functioning, and mental health). Each scale is directly transformed into a 0-100 scale for a total score range of 0-800. Higher scores represent a more favorable health status. This test was performed twice, once at the end of each intervention period.

  3. Cardiopulmonary Exercise Testing (CPET) [Performed on day 14 and day 21.]

    Cardiovascular health benefits were determined by measuring the peak heart rate (HR) during Cardiopulmonary exercise testing (CPET). The CPET is performed on a standard treadmill according to the Naughton protocol. During the test, patients inspired room air through a low-resistance mask, and expired oxygen and carbon dioxide partial pressures were measured with a gas analyzer. HR was recorded every 30 seconds during exercise. All patients were encouraged to exercise to maximal effort. This test was performed twice, once at the end of each intervention period.

  4. Patient Preference [Performed on day 21.]

    At the end of the study, patients were asked about personal preference regarding CLS over DDDR.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  • Current persistent atrial fibrillation

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Sulpizio Cardiovascular CenterLa JollaCaliforniaUnited States92037

Sponsors and Collaborators

  • University of California, San Diego
  • Biotronik, Inc.

Investigators

  • Principal Investigator: Jonathan Hsu, MD, University of California, San Diego

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Jonathan Hsu, Assistant Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02693262
Other Study ID Numbers:
  • 151774
First Posted:
Feb 26, 2016
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jonathan Hsu, Assistant Professor of Medicine, University of California, San Diego
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsPatients with HFrEF and CI implanted with a CRT-D capable of CLS programming at UCSD were eligible for this study. 102 patients were screened.
Pre-assignment Detail12 patients signed consent form. 3 participants dropped out of study prior to randomization. 9 participants were randomized and completed study.
Arm/Group TitleCLS, Then DDDRDDDR, Then CLS
Arm/Group DescriptionParticipants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of CLS followed by 1 week of DDDR.Participants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of DDDR followed by 1 week of CLS.
Period Title: Overall Study
STARTED45
COMPLETED45
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleAll Study Participants
Arm/Group DescriptionAll participants were randomized to receive all interventions, therefore baseline characteristics will be reported together.
Overall Participants9
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
1
11.1%
>=65 years
8
88.9%
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]
69
Sex: Female, Male (Count of Participants)
Female
4
44.4%
Male
5
55.6%
Race/Ethnicity, Customized (Count of Participants)
White
6
66.7%
Other
3
33.3%
Region of Enrollment (Count of Participants)
United States
9
100%

Outcome Measures

1. Primary Outcome
TitleSix-minute Walk Distance (6MWD) Test
DescriptionCardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period.
Time FrameMeasured on day 14 and day 21.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Arm/Group DescriptionAll 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Measure Participants99
Mean (Standard Deviation) [meters]
293.1
(90.2)
315.1
(95.5)
2. Primary Outcome
TitleRAND-36 Questionnaire
DescriptionQuality of life of subjects was measured by the RAND-36 which is a generic 36-item questionnaire that measures eight health-related domains stratified by physical health (physical functioning, role limitations due to physical health, pain, and general health) and emotional health (vitality, role limitations due to emotional problems, social functioning, and mental health). Each scale is directly transformed into a 0-100 scale for a total score range of 0-800. Higher scores represent a more favorable health status. This test was performed twice, once at the end of each intervention period.
Time FramePerformed on day 14 and day 21.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Arm/Group DescriptionAll 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Measure Participants99
Mean (Standard Deviation) [score on a scale]
550.8
(123.9)
489.3
(164.9)
3. Primary Outcome
TitleCardiopulmonary Exercise Testing (CPET)
DescriptionCardiovascular health benefits were determined by measuring the peak heart rate (HR) during Cardiopulmonary exercise testing (CPET). The CPET is performed on a standard treadmill according to the Naughton protocol. During the test, patients inspired room air through a low-resistance mask, and expired oxygen and carbon dioxide partial pressures were measured with a gas analyzer. HR was recorded every 30 seconds during exercise. All patients were encouraged to exercise to maximal effort. This test was performed twice, once at the end of each intervention period.
Time FramePerformed on day 14 and day 21.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Arm/Group DescriptionAll 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Measure Participants99
Mean (Standard Deviation) [beats per minute]
110.7
(14.7)
109.7
(14.1)
4. Primary Outcome
TitlePatient Preference
DescriptionAt the end of the study, patients were asked about personal preference regarding CLS over DDDR.
Time FramePerformed on day 21.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Arm/Group DescriptionAll 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Measure Participants99
Count of Participants [Participants]
5
55.6%
4
NaN

Adverse Events

Time FramePatients were followed during the whole 3 week study period for any adverse events, assessed on day 0, day 7, day 14 and day 21.
Adverse Event Reporting Description
Arm/Group TitleCLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Arm/Group DescriptionAll 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
All Cause Mortality
CLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)
Serious Adverse Events
CLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
CLS Mode on Biotronik CRT-DAccelerometer Mode on Biotronik CRT-D
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/9 (0%) 0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleJonathan Hsu, MD, MAS
OrganizationUniversity of California, San Diego
Phone858-246-2972
Emailjonathan.hsu@ucsd.edu
Responsible Party:
Jonathan Hsu, Assistant Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02693262
Other Study ID Numbers:
  • 151774
First Posted:
Feb 26, 2016
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021