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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229137
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
Assessment of sensor parameter in patients with heart failure.

Condition or disease Intervention/treatment
Heart Failure Device: SRD-1 conversion

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

Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229137

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

Responsible Party: Boston Scientific Corporation Identifier: NCT01229137     History of Changes
Other Study ID Numbers: PRE-SENSE
G100110 ( Other Identifier: FDA )
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases