Chronotropic Incompetence Clinical Trial
Official title:
The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI
The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker sensor which responds only by comparing physical activity, heart rate, and breathing rate; compared to the accelerometer pacemaker sensor which respond only by comparing physical activity and the heart rate in patients whose heart is unable increase its heart rate according to increase physical activity or demand (Chronotropic Incompetence). Only one pacemaker family will be used in this clinical trial whereas the "out of box" configuration is the blended sensor which can also be made to act only as an accelerometer.
Objective: The goal of this trial is to test the impact of individualized blended sensor
optimization on chronotropic response, compared with accelerometer use alone, in patients
with chronotropic incompetence who are planned to undergo permanent pacemaker (PPM)
implantation.
Study Population: The study population will consist of patients who suffer from the heart's
inability to increase its heart rate according to increased physical activity or demand
(chronotropic incompetence). These patients are planned to undergo permanent pacemaker (PPM)
implantation.
PRIMARY ENDPOINT: Improvement in chronotropic competence as defined as an increase in
age-predicted maximum heart rate (APMHR) which is defined as 220 beats per minute (bpm)
minus patient's age in years. Age-predicted heart rate reserve (APMHR) defined as APMHR
minus patient's heart rate at rest. Observe the maximal heart rate during exercise test with
decrease in oxygen consumption at each stage and also at peak effort.
SECONDARY ENDPOINT:
1. Quality of life.
2. Procedural safety as defined by the number of complications within 1week associated
with the procedure.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02003378 -
Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer
|
N/A | |
Completed |
NCT03871803 -
β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)
|
Phase 4 | |
Completed |
NCT01030705 -
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
|
N/A | |
Completed |
NCT02693262 -
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
|
N/A | |
Recruiting |
NCT05649787 -
Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence
|
N/A | |
Recruiting |
NCT03235843 -
Rate Adaptive Atrial Pacing in Heart Failure
|
N/A | |
Completed |
NCT02145351 -
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
|
N/A | |
Recruiting |
NCT03844516 -
Pacing in Left Ventricular Assist Device Recipients
|
N/A |