Clinical trial NCT01619800: The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise
Official title: The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronotropic Incompetence
Keywords: Chronotropic Incompetence
Pacemaker
Mount Sinai School of Medicine
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2012-06-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changed in Stress Test at 6 Months as Compared to Baseline
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: