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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
History of Changes

October 25, 2010
September 10, 2012
June 2011
August 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01229137 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Assessment of sensor parameter in patients with heart failure.

Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Heart failure patients with an implanted CRT-D
Heart Failure
Device: SRD-1 conversion
  • Right Ventricular Cohort
    Right Ventricle wtih SRD-1 conversion
    Intervention: Device: SRD-1 conversion
  • Left Ventricular Cohort
    Left Ventricle with SRD-1 conversion
    Intervention: Device: SRD-1 conversion
  • Right Atrium Cohart
    Right atrium cohort with SRD-1 conversion
    Intervention: Device: SRD-1 conversion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01229137
PRE-SENSE, G100110
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Alan Bank, M.D. United Heart and Vascular Center
Boston Scientific Corporation
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP