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

The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI

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.

Study Overview

• Status: Terminated
• Conditions: Chronotropic Incompetence
• Intervention / Treatment: Device: Blended Sensor Optimization (BSO); Device: Accelerometer Alone (AA)

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blended Sensor Optimization (BSO); 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); 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.
Sham Comparator: Accelerometer Alone (AA); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and 6 months

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 14, 2012

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 15, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Pacemaker; Chronotropic Incompetence; Mount Sinai School of Medicine
• Other Study ID Numbers: 11-02-333-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No