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CompletedNCT01229137PRE-SENSEUpdated Sep 12, 2012

Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

An observational study in Heart Failure, sponsored by Boston Scientific Corporation. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-12.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
01

Study summary

Assessment of sensor parameter in patients with heart failure.

Read the detailed description

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

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 71 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart failure patients with an implanted CRT-D

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
71 participants (actual)

Groups and cohorts

  • 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

Interventions

  • DeviceSRD-1 conversion
06

Study locations

14 sites
  • Cardiovascular Associates of Northeast Arkansas
    Jonesboro, Arkansas 72401, United States
  • Regional Cardiology Consultants
    Sacremento, California 95819, United States
  • Danbury Hospital
    Danbury, Connecticut 06810, United States
  • Heart and Vascular Institute of Florida
    Clearwater, Florida 33756, United States
  • Genesis Medical Center
    Davenport, Iowa 52803, United States
  • University of Massachusetts Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • St. John's Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • United Heart and Vascular Clinic
    St. Paul, Minnesota 55102, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Cardiovascular Research Institure, LLC
    Canton, Ohio 44708, United States
  • Texas Cardiac Arrhythmia Research
    Austin, Texas 78705, United States
  • Tyler Cardiovascular Associates
    Tyler, Texas 75701, United States
  • Thomas Bunch
    Murray, Utah 84157, United States
  • University of Virginia Medical Center
    Charlottesville, Virginia 22908, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01229137
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Oct 27, 2010
Start date
Jun 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Sep 12, 2012

Study contacts

Alan Bank, M.D.
principal investigator · United Heart and Vascular Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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