Physiological Response to Exercise: Sensor Evaluation at Specified Exertions (PRE-SENSE)

September 10, 2012 updated by: Boston Scientific Corporation
Assessment of sensor parameter in patients with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Cardiovascular Associates of Northeast Arkansas
    • California
      • Sacremento, California, United States, 95819
        • Regional Cardiology Consultants
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Heart and Vascular Institute of Florida
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48236
        • St. John's Hospital and Medical Center
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • United Heart and Vascular Clinic
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44708
        • Cardiovascular Research Institure, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
      • Tyler, Texas, United States, 75701
        • Tyler Cardiovascular Associates
    • Utah
      • Murray, Utah, United States, 84157
        • Thomas Bunch
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients with an implanted CRT-D

Description

Inclusion Criteria:

  • COGNIS CRT-D model N119 or N120, functional bipolar leads: RA, RV, and LV lead all implanted for a minimum of 30 days
  • Prescribed to optimal pharmacologic therapy for heart failure for at least 30 days prior to enrollment
  • Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  • Documented HF decompensation, as defined by a hospitalization or greater than a doubling of baseline diuretic dose due to worsening HF, within the last 3 months
  • Patients who are pacemaker dependent
  • Creatinine ≥ 2.5 mg/dL test within the last 3 months
  • Requires assistance walking, for example a cane or walker
  • Have an atrial tachyarrhythmia that is permanent or persistent
  • Have moderate to severe chronic pulmonary disease as defined by FEV1 < 55% predicted
  • Documented life expectancy of less than 6 months
  • Patients at an unreasonable risk of not being able to reach the investigational center in case of an emergency, per physician discretion
  • Enrolled in any concurrent study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Right Ventricular Cohort
Right Ventricle wtih SRD-1 conversion
Device: SRD-1 conversion
Left Ventricular Cohort
Left Ventricle with SRD-1 conversion
Device: SRD-1 conversion
Right Atrium Cohart
Right atrium cohort with SRD-1 conversion
Device: SRD-1 conversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Alan Bank, M.D., United Heart and Vascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (ESTIMATE)

October 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRE-SENSE
  • G100110 (OTHER: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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