Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
PRE-SENSE
2 other identifiers
observational
71
1 country
14
Brief Summary
Assessment of sensor parameter in patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2011
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
October 27, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 12, 2012
September 1, 2012
1.2 years
October 25, 2010
September 10, 2012
Conditions
Study Arms (3)
Right Ventricular Cohort
Right Ventricle wtih SRD-1 conversion
Left Ventricular Cohort
Left Ventricle with SRD-1 conversion
Right Atrium Cohart
Right atrium cohort with SRD-1 conversion
Interventions
Eligibility Criteria
Heart failure patients with an implanted CRT-D
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Saint 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Bank, M.D.
United Heart and Vascular Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
October 27, 2010
Study Start
June 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 12, 2012
Record last verified: 2012-09