Chronotropic Incompetence
Conditions
Keywords
Chronotropic Incompetence, Pacemaker, Mount Sinai School of Medicine
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBlended Sensor Optimization (BSO)
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.
DEVICEAccelerometer Alone (AA)
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.
Sponsors
Boston Scientific Corporation
Vivek Reddy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changed in Stress Test at 6 Months as Compared to Baseline | baseline and 6 months | An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blended Sensor Optimization (BSO) Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated | 2 |
| Accelerometer Alone (AA) Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study terminated | 2 | 0 |
Baseline characteristics
| Characteristic | Blended Sensor Optimization (BSO) | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
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