The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise
Stopped early · Not applicable · Has a placebo group
Conditions studied: Chronotropic Incompetence
In brief
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.
Key facts
- Study ID
- NCT01619800
- Run by
- Vivek Reddy
- People needed
- 2
- Starts
- 2012-03-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Evidence of chronotropic incompetence on exercise or pharmacological stress test defined as the inability to achieve 85% or greater of Age-predicted heart rate reserve (APMHR)
- Legal status to give informed consent specific to state and national law.
- Planned for PPM implantation and meets current guidelines for PPM therapy.
You may not qualify if…
- Inability to give informed consent
- Inability to comply with the follow-up visit schedule.
- Unable to participate in stress testing (exercise or pharmacological).
- Previous PPM implantation
- A life expectancy of less than 12 months per physician discretion
- Enrolled in any concurrent study, without Boston Scientific written approval.
- Pregnancy
- Unstable chest pain
- Stroke within 30 days
- Heart attack within 90 days
- Stress Test Exclusion Criteria: No evidence of Chronotropic incompetence on exercise or pharmacological stress test, defined as the ability to achieve 85% or greater of APMHR.
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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