Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
MRICEMAN
A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
1 other identifier
interventional
300
1 country
2
Brief Summary
The study will assess the atrial fibrillation burden recorded By implantable loop recorder at 12 and 24 months compared to baseline. The patients with clinical indication fo catheter ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and cryoablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 atrial-fibrillation
Started Jan 2016
Typical duration for phase_4 atrial-fibrillation
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 24, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 28, 2015
December 1, 2015
3.9 years
December 9, 2015
December 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Free of atrial fibrillation
the proportion of patients remaining free from AF, atrial flutter (AFL) or atrial tachycardia (AT) (\> 2 minutes) recorded by the implantable cardiac monitor (ICM, Reveal, Medtronic Co.) at 24 months.
24 months
Secondary Outcomes (2)
Total AF burden
24 months
Incidence of adverse events
24 months
Study Arms (3)
manual radiofrequency ablation
ACTIVE COMPARATORRadiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.
magnet navigation ablation
ACTIVE COMPARATORRadiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.
cryoablation
ACTIVE COMPARATORCatheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.
Interventions
Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation. The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.
Eligibility Criteria
You may qualify if:
- Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation
You may not qualify if:
- \- Any contraindication to catheter ablation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heikki Huikurilead
- University of Helsinkicollaborator
Study Sites (2)
UOulu
Oulu, 90014, Finland
Heikki Huikuri
Oulu, Finland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heikki Huikuri, Prof
University of Oulu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2015
First Posted
December 24, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
December 28, 2015
Record last verified: 2015-12