Study Stopped
Recruitment to study was insufficient. This was despite extending the recruitment period. Decision taken to terminate study due to lack of recruitment.
Comparison of the Performance of ICM and CIED in Detecting AF
ID-AF
1 other identifier
interventional
6
1 country
1
Brief Summary
The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2023
CompletedResults Posted
Study results publicly available
October 15, 2024
CompletedOctober 15, 2024
July 1, 2024
2.1 years
June 17, 2021
June 19, 2024
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Performance of Confirm Rx ICM and Reveal LINQ ICM in Detecting AF Episodes in Comparison to CIED
To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.
During follow-up (6 months)
Secondary Outcomes (3)
Comparison of Changes in R-wave Amplitude Following Implantation in Both ICMs.
During follow-up (6 months)
To Compare the Transmission Success Rate of Both Devices.
During follow-up (6 months)
To Compare the Number of Patient-activated Recordings That Contains Symptoms.
During follow-up (6 months)
Study Arms (2)
Patients implanted with the Abbott Confirm Rx ICM
OTHERPatient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.
Patients implanted with the Medtronic LINQ ICM
OTHERPatient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.
Interventions
Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
Eligibility Criteria
You may qualify if:
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female.
- Aged 18 years or above.
- History of paroxysmal and persistent AF.
- Dual-chamber pacemaker, Implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) device with a functioning atrial lead, able to record electrograms and remote monitoring.
You may not qualify if:
- Diagnosis of permanent AF.
- Contra-indications for implantable cardiac monitor.
- Unable to comply with the follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Radcliffe Hospital
Oxford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Richard Varini
- Organization
- Oxford University Hospitals NHS Trust
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Betts, MD FRCP
Oxford University Hospitals NHS Trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 25, 2021
Study Start
October 4, 2021
Primary Completion
November 23, 2023
Study Completion
November 23, 2023
Last Updated
October 15, 2024
Results First Posted
October 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share