An interventional study of Blended Sensor Optimization (BSO) and Accelerometer Alone (AA) in Chronotropic Incompetence, sponsored by Vivek Reddy. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Vivek Reddy · Not applicable, Interventional, and Supportive care
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:
Vivek Reddy is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
Device: Blended Sensor Optimization (BSO)
Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
Device: Accelerometer Alone (AA)
At wound check (POD#1 and 1 Week F/U), histograms from device interrogation obtained from patients in the BSO group are assessed, and these patients undergo optimization. A hall walk and stair climbing exercise will be performed and MV optimized using trending data to hit the following targets: HR at Rest: 60 HR upon slow walking: 100 HR upon brisk walking: 115-120 HR upon climbing stairs: 130-135 Patients will undergo optimization, and be instructed that their device may have been optimized.
Patients in the AA group will also undergo device interrogation, and will perform a hall walk and stair climbing exercise. Afterwards, these patients will undergo a sham optimization by placing the PPM interrogation laptop device over there pacemaker, and instructing the patients that their device may have been optimized.
Changed in Stress Test at 6 Months as Compared to Baseline
An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.
Time frame: baseline and 6 months
| Milestone | Blended Sensor Optimization (BSO) | Accelerometer Alone (AA) |
|---|---|---|
| Started | 2 | 0 |
| Completed | 0 | 0 |
| Not completed | 2 | 0 |
| Withdrew: Study terminated | 2 | 0 |
An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.
No measurements were reported for this outcome.
Collected over 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blended Sensor Optimization (BSO) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Accelerometer Alone (AA) | — | — | — |
| Age, Categorical(Participants) | Blended Sensor Optimization (BSO) | Accelerometer Alone (AA) | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 1 | — | 1 |
| >=65 years | 1 | — | 1 |
| Sex: Female, Male(Participants) | Blended Sensor Optimization (BSO) | Accelerometer Alone (AA) | Total |
|---|---|---|---|
| Female | 2 | — | 2 |
| Male | 0 | — | 0 |
Plan to share: No
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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Vivek Reddy