Completed

Remote Implant Support

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Remote Implant Support Capability

Other
Who is being recruted

Arrhythmias, Cardiac+7

+ Cardiovascular Diseases

+ Death

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorMedtronic Cardiac Rhythm and Heart Failure
Last updated: April 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2013

Actual date on which the first participant was enrolled.

The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics. The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.

NCT01809652
Principal SponsorMedtronic Cardiac Rhythm and Heart Failure
Last updated: April 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

37 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesDeathDeath, SuddenHeart ArrestHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBradycardiaDeath, Sudden, Cardiac

Criteria

2 inclusion criteria required to participate
Planned IPG implant or planned ICD (without CRT) implant
Signed informed consent
6 exclusion criteria prevent from participating
Basal ventricular rate > 110 beats per minute
Currently involved in another IPG or ICD related clinical trial
Defibrillation threshold testing planned
Pacing dependency
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Implant supported through remote implant support capability

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centennial Heart

Nashville, United StatesOpen Centennial Heart in Google Maps
CompletedOne Study Center