Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Completed

• Conditions: Heart Failure
• Interventions: Device: SRD-1 conversion

• Registration Number: NCT01229137
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Assessment of sensor parameter in patients with heart failure.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-27
• Study Start: 2011-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Right Atrium Cohart	SRD-1 conversion	Right atrium cohort with SRD-1 conversion
Right Ventricular Cohort	SRD-1 conversion	Right Ventricle wtih SRD-1 conversion
Left Ventricular Cohort	SRD-1 conversion	Left Ventricle with SRD-1 conversion

Trial Locations

Locations (14)

Cardiovascular Associates of Northeast Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Regional Cardiology Consultants; 🇺🇸 Sacremento, California, United States

Heart and Vascular Institute of Florida; 🇺🇸 Clearwater, Florida, United States

Cardiovascular Research Institure, LLC; 🇺🇸 Canton, Ohio, United States

Thomas Bunch; 🇺🇸 Murray, Utah, United States

Genesis Medical Center; 🇺🇸 Davenport, Iowa, United States

Texas Cardiac Arrhythmia Research; 🇺🇸 Austin, Texas, United States

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

St. John's Hospital and Medical Center; 🇺🇸 Detroit, Michigan, United States

Tyler Cardiovascular Associates; 🇺🇸 Tyler, Texas, United States

Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

United Heart and Vascular Clinic; 🇺🇸 St. Paul, Minnesota, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States