Reveal LINQ Respiration Clinical Study

Respiratory Rate Clinical Trial

Official title:

Reveal LINQ Respiration Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506684
• Other study ID #: MDT20022
• Status: Completed
• Start date: September 25, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The LINQ™ Respiration study will collect and characterize Reveal LINQ™ derived respiration data from patients undergoing a simulated 24-hour time period while being monitored with capnography.

Description:

The Reveal LINQ™ Respiration study is a Non-Significant Risk IDE, observational, non-randomized, multi-center, clinical study. The study is expected to be conducted at up to 5 centers in the United States and up to 100 subjects will be enrolled, with no more than 25 subjects enrolled per site. In addition, a minimum of 30% of all enrolled subjects will have a history of heart failure.

All enrolled subjects will either have the investigational LINQ HF or ALLEVIATE-HF RAMware downloaded onto their implanted Reveal LINQ device, Holter monitor and capnography monitor applied and undergo a series of activity and breathing maneuvers. The expected duration of subject participation in the study (from start of study procedures to study exit) is approximately 1.5 hours. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 3 months.

All Adverse events will be collected throughout the study duration of a subject's participation in the study, beginning at the time of informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 55 years old

• Patient (or patient's legally authorized representative) is willing and able to provide written informed consent

• Patient is willing and able to comply with the study procedures

• Patient has an active Medtronic Reveal LINQ device that has been implanted for = 60 days and no more than 3 years

Exclusion Criteria:

• Patient has an existing condition that necessitates the use of supplemental oxygen

• Patient has an active acute respiratory infection or a respiratory disorder that may affect ability to perform respiratory maneuvers

• Patient has NYHA Class IV heart failure per most recent assessment

• Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator

• Patient is enrolled in another study that could confound the results of this study

• Patient has an existing implantation of Medtronic IPG, ICD, CRT-D or CRT-P device

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

Device:
• Investigational RAMware downloaded onto Reveal LINQ device
The study is utilizing an investigational RAMware, either LINQ HF or ALLEVIATE-HF, that will be downloaded onto the subject's market-released Medtronic Reveal LINQ ICM. The investigational RAMware enables the hardware to record and store additional sensor data from which a respiratory rate will be derived.

Locations

Country	Name	City	State
United States	Cardiac Arrhythmia Service	Boca Raton	Florida
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrating an agreement between LINQ and capnography derived respiratory rate	The primary objective is to demonstrate an acceptable agreement between Reveal LINQ™ derived respiratory rate and capnography waveform-derived respiratory rate.	6 months
Secondary	Characterizing the agreement between LINQ and capnography derived respiratory rate	The secondary objective is to characterize the agreement between Reveal LINQ™ derived respiratory rate with capnography waveform-derived respiratory rate utilizing all paired measurements captured during the study protocol.	6 months