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

This study has been terminated.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01619800
First received: June 12, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronotropic Incompetence
Device: Blended Sensor Optimization (BSO)
Device: Accelerometer Alone (AA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The impAct of Blended Sensor Optimization on resoLVing Chronotropic Incompetence: ABSOLVE CI

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Changed in Stress Test at 6 months as compared to baseline [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Exercise or Dobumatime Stress Test


Secondary Outcome Measures:
  • Change in Quality of Life at 6 months as compared to baseline [ Time Frame: at baseline and at 6 months ] [ Designated as safety issue: No ]
    Quality of Life Survey


Enrollment: 2
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619800

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Boston Scientific Corporation
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01619800     History of Changes
Other Study ID Numbers: 11-02-333-05
Study First Received: June 12, 2012
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Chronotropic Incompetence
Pacemaker
Mount Sinai School of Medicine

ClinicalTrials.gov processed this record on July 20, 2014