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

NCT01619800 | Terminated Results DMC

• 1 other identifier: 11-02-333-05
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronotropic Incompetence

Keywords

Chronotropic Incompetence; Pacemaker; Mount Sinai School of Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Blended Sensor Optimization (BSO)

EXPERIMENTAL

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)

Accelerometer Alone (AA)

SHAM COMPARATOR

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)

Interventions

Blended Sensor Optimization (BSO) DEVICE

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.

Blended Sensor Optimization (BSO)

Accelerometer Alone (AA) DEVICE

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.

Accelerometer Alone (AA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivek Reddy: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Limitations and Caveats

2 subjects enrolled, unable to meet goal of 38 enrollments. Data not analyzed.

Results Point of Contact

• Title: Vivek Reddy
• Organization: Icahn School of Medicine at Mount Sinai

vivek.reddy@mountsinai.org

212-241-7114

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Professor Of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 18, 2017
• Results First Posted: March 2, 2015

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)