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

NCT02693262 | Completed Results

• 1 other identifier: 151774
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; ICD; Chronotropic Incompetence

Keywords

defibrillator; heart failure; ICD; CRT-D; cardiac resynchronization therapy; rate response; CLS; closed-loop stimulation; accelerometer; chronotropic incompetence

Outcome Measures

Primary Outcomes (4)

• Six-minute Walk Distance (6MWD) Test

  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.

  Measured on day 14 and day 21.

• RAND-36 Questionnaire

  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.

  Performed on day 14 and day 21.

• Cardiopulmonary Exercise Testing (CPET)

  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.

  Performed on day 14 and day 21.

• Patient Preference

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

  Performed on day 21.

Study Arms (2)

CLS Mode on Biotronik CRT-D

EXPERIMENTAL

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

Accelerometer Mode on Biotronik CRT-D

ACTIVE COMPARATOR

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

Interventions

CLS Mode on Biotronik CRT-D DEVICE

Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.

CLS Mode on Biotronik CRT-D

Accelerometer Mode on Biotronik CRT-D DEVICE

Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.

Accelerometer Mode on Biotronik CRT-D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Biotronik, Inc.: collaborator

Study Sites (1)

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Publications (8)

• Alt E. What is the ideal rate-adaptive sensor for patients with implantable cardioverter defibrillators: lessons from cardiac pacing. Am J Cardiol. 1999 Mar 11;83(5B):17D-23D. doi: 10.1016/s0002-9149(98)01038-8.

  PMID: 10089835 BACKGROUND

• Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408. doi: 10.1161/CIRCUALTIONAHA.108.189742. Epub 2008 May 15. No abstract available.

  PMID: 18483207 BACKGROUND

• Freedman RA, Hopper DL, Mah J, Hummel J, Wilkoff BL. Assessment of pacemaker chronotropic response: implementation of the Wilkoff mathematical model. Pacing Clin Electrophysiol. 2001 Dec;24(12):1748-54. doi: 10.1046/j.1460-9592.2001.01748.x.

  PMID: 11817808 BACKGROUND

• Maass AH, Buck S, Nieuwland W, Brugemann J, van Veldhuisen DJ, Van Gelder IC. Importance of heart rate during exercise for response to cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2009 Jul;20(7):773-80. doi: 10.1111/j.1540-8167.2008.01422.x. Epub 2009 Feb 2.

  PMID: 19207785 BACKGROUND

• Coenen M, Malinowski K, Spitzer W, Schuchert A, Schmitz D, Anelli-Monti M, Maier SK, Estlinbaum W, Bauer A, Muehling H, Kalscheur F, Puerner K, Boergel J, Osswald S. Closed loop stimulation and accelerometer-based rate adaptation: results of the PROVIDE study. Europace. 2008 Mar;10(3):327-33. doi: 10.1093/europace/eun024. Epub 2008 Feb 13.

  PMID: 18272507 BACKGROUND

• Tse HF, Siu CW, Lee KL, Fan K, Chan HW, Tang MO, Tsang V, Lee SW, Lau CP. The incremental benefit of rate-adaptive pacing on exercise performance during cardiac resynchronization therapy. J Am Coll Cardiol. 2005 Dec 20;46(12):2292-7. doi: 10.1016/j.jacc.2005.02.097.

  PMID: 16360061 BACKGROUND

• Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS, Kraus WE; HF-ACTION Investigators. Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014.

  PMID: 19782792 BACKGROUND

• Hsu JC, Darden D, Alegre M, Birgersdotter-Green U, Feld GK, Hoffmayer KS, Han F, Krummen D, Raissi F, Ho G, Taub PR, Urey MA, Adler E. Effect of closed loop stimulation versus accelerometer on outcomes with cardiac resynchronization therapy: the CLASS trial. J Interv Card Electrophysiol. 2021 Sep;61(3):479-485. doi: 10.1007/s10840-020-00829-4. Epub 2020 Aug 5.

  PMID: 32757086 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jonathan Hsu, MD, MAS
• Organization: University of California, San Diego

jonathan.hsu@ucsd.edu

858-246-2972

Study Officials

• Jonathan Hsu, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: February 26, 2016
• Study Start: July 1, 2016
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)