Overview

This trial is active, not recruiting.

Condition breathing exercises
Treatment respiration assessment
Sponsor Medtronic BRC
Start date July 2015
End date December 2015
Trial size 20 participants
Trial identifier NCT02828735, EPIQ

Summary

The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
respiration assessment

Primary Outcomes

Measure
feasibility of respiration detection
time frame: up to 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure. - Chronic Kidney Disease (CKD) in Stage 5 (GFR = <15 mL/min). - Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible). - Willing to sign the informed consent form. - Greater than 18 years of age. Exclusion Criteria: - Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager. - Significant respiratory diseases such as COPD or pulmonary hypertension. - Frequent arrhythmias, including PVC's. - Known systolic heart failure. - Recent infection. - Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method. - Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc). - Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study. - Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest. - Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes. - Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.

Additional Information

Official title REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
Principal investigator Mpiko Ntsekhe
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic BRC.