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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01229137
First received: October 25, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

Assessment of sensor parameter in patients with heart failure.


Condition Intervention Phase
Heart Failure
Device: SRD-1 conversion
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Enrollment: 71
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart failure patients with an implanted CRT-D

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229137

Locations
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
Investigators
Principal Investigator: Alan Bank, M.D. United Heart and Vascular Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01229137     History of Changes
Other Study ID Numbers: PRE-SENSE, G100110
Study First Received: October 25, 2010
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014