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Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer

NCT02003378 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-12-06

No results posted yet for this study

Summary

Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer) and/or breathing changes (known as minute ventilation). These changes in motion or breathing make the pacemaker increase the patient's heart rate. This study is being conducted to see which rate response sensor is better (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the minute ventilation sensor results in improved functional capacity compared to accelerometer in chronotropically incompetent patients.

Conditions

  • Chronotropic Incompetence

Interventions

DEVICE

Pacemaker sensor set to MV

Pacemaker sensor set to minute ventilation

DEVICE

Pacemaker sensor set to XL

Pacemaker sensor set to accelerometer

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Sujata Balulad, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02003378 on ClinicalTrials.gov