The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise (ABSOLVE CI)

Vivek Reddy

Status: Terminated

Conditions: Chronotropic Incompetence

Treatments: Device: Accelerometer Alone (AA); Device: Blended Sensor Optimization (BSO)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01619800

11-02-333-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2 participants in 2 patient groups

Blended Sensor Optimization (BSO)

Experimental group

Description:

Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated

Treatment:

Device: Blended Sensor Optimization (BSO)

Accelerometer Alone (AA)

Sham Comparator group

Description:

Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active

Treatment:

Device: Accelerometer Alone (AA)