Reveal and Carelink (Real Care): Does using remote monitoring in combination with Implantable Loop Recorders reduce the time to diagnosis?

Reveal and Carelink (Real Care): Does using remote monitoring in combination with Implantable Loop Recorders reduce the time to diagnosis? A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72340423

Enrollment

Registered

2014-04-28

Start date

2013-11-20

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope / TLoc and Palpitations - Cardiovascular Medicine Circulatory System

Interventions

Experimental Group - Addition of Carelink remote monitoring equipment provided by Medtronic Inc. Data from implantable loop recorder to be viewed fortnightly. Patients in the Control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Implanted with a Medtronic Reveal DX or XT ILR 2. Over 18 years of age 3. Are themselves cognitively capable of consenting 4. Have the ability, or have a willing and appropriate adult to use any equipment and comply with the control and Carelink pathway 5. Are able to communicate using, or understand instructions given in, English

Exclusion criteria

Exclusion criteria: 1. Patients that do not have access to a landline telephone 2. If they have documented cognitive impairment that means that they are unable to consent for themselves 3. Do not have the ability or a willing and appropriate adult to comply with the use of any equipment or they are unable to follow the control and Carelink care pathways 4. Patients that cannot communicate using, or understand instructions given in, English

Design outcomes

Primary

Measure	Time frame
Time to patient diagnosis or non-cardiac outcome within the 24-month follow-up period.	—

Secondary

Measure	Time frame
1. Which follow-up method promotes the least device memory saturation 2. Are more patients diagnosed via automated recordings or manual recordings 3. Impact in terms of time and resources required of running remote monitoring clinics within CDDFT hospitals Patients will be reviewed at baseline (1 month post implant/enrolment) then 6 monthly or if symptoms occur for control group patients and fortnightly or if symptoms occur for experimental group patients. A participant is considered to have a cardiac diagnosis if they are treated for a cardiac problem that could be the cause of their symptoms, such as asystole, bradycardia or tachycardia other than sinus tachycardia. Treatment could be in the form of medication, a cardiac device (pacemaker, ICD or CRT) or any other form of cardiac rate or rhythm management therapy. Participants may receive a non-cardiac diagnosis as the cause for their symptoms; this is considered to be the case if a participant makes a manual recording whilst symptomatic on two or more occasions. Finally, previous data suggests that there will be a small number of participants that will not have any symptoms during the 24-month follow-up period, these participants will receive no diagnosis.	—

Measure

Time frame

1. Which follow-up method promotes the least device memory saturation 2. Are more patients diagnosed via automated recordings or manual recordings 3. Impact in terms of time and resources required of running remote monitoring clinics within CDDFT hospitals Patients will be reviewed at baseline (1 month post implant/enrolment) then 6 monthly or if symptoms occur for control group patients and fortnightly or if symptoms occur for experimental group patients. A participant is considered to have a cardiac diagnosis if they are treated for a cardiac problem that could be the cause of their symptoms, such as asystole, bradycardia or tachycardia other than sinus tachycardia. Treatment could be in the form of medication, a cardiac device (pacemaker, ICD or CRT) or any other form of cardiac rate or rhythm management therapy. Participants may receive a non-cardiac diagnosis as the cause for their symptoms; this is considered to be the case if a participant makes a manual recording whilst symptomatic on two or more occasions. Finally, previous data suggests that there will be a small number of participants that will not have any symptoms during the 24-month follow-up period, these participants will receive no diagnosis.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026