Skip to main content
OpenTrials
Completed

NCT Number: NCT01229137

Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Assessment of sensor parameter in patients with heart failure.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Associates of Northeast Arkansas, Jonesboro, Arkansas, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRD-1 conversion

Device

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: PRE-SENSE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2010
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.