The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Changed in Stress Test at 6 Months as Compared to Baseline
Study Overview
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:
- Quality of life.
- Procedural safety as defined by the number of complications within 1week associated with the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 Exclusion Criteria: No evidence of Chronotropic incompetence on exercise or pharmacological stress test, defined as the ability to achieve 85% or greater of APMHR.
Arms & Interventions
Blended Sensor Optimization (BSO)
Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
Intervention: Blended Sensor Optimization (BSO) (Device)
Accelerometer Alone (AA)
Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
Intervention: Accelerometer Alone (AA) (Device)
Outcomes
Primary Outcomes
Changed in Stress Test at 6 Months as Compared to Baseline
Time Frame: baseline and 6 months
An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.
Secondary Outcomes
No secondary outcomes reported
Investigators
Vivek Reddy
Director Cardiac Arrhythmia Service, Professor Of Medicine
Icahn School of Medicine at Mount Sinai