N/A
Completed N=9
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Heart Failure · ICD · Chronotropic Incompetence
Source: ClinicalTrials.gov NCT02693262 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Six-minute Walk Distance (6MWD) Test — 293.1; 315.1 meters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six-minute Walk Distance (6MWD) Test |
293.1; 315.1 | — |
| PRIMARY RAND-36 Questionnaire |
550.8; 489.3 | — |
| PRIMARY Cardiopulmonary Exercise Testing (CPET) |
110.7; 109.7 | — |
| PRIMARY Patient Preference |
5; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02693262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.