Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download for Hypesthesia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hypesthesia+2 More
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to manage heart failure that uses an algorithm to guide patient care. The goal is to show that this is safe and effective.

Eligible Conditions
  • Hypesthesia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Up to 3 years

Month 13
Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance
Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate
Up to 3 years
Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events
Safety of the patient management pathway (i.e. proportion of medication interventions with associated medication intervention related serious adverse events)
Month 6
Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Intervention Arm
1 of 2
Observation Arm
1 of 2

Experimental Treatment

Non-Treatment Group

700 Total Participants · 2 Treatment Groups

Primary Treatment: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download · Has Placebo Group · N/A

Intervention ArmExperimental Group · 2 Interventions: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download, Medication intervention · Intervention Types: Device, Other
Observation Arm
Device
PlaceboComparator Group · 1 Intervention: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
193 Previous Clinical Trials
130,865 Total Patients Enrolled
Javed Butler, MDPrincipal InvestigatorUniversity of Mississippi Medical Center
4 Previous Clinical Trials
4,020,759 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient is willing and able to comply with the protocol, including LINQ ICM insertion, CareLink transmissions (including adequate connectivity), study visits and remote care directions.
You have NYHA Class II or III heart failure

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.