Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
NCT ID: NCT02639793
Last Updated: 2015-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2016-01-31
2020-01-31
Brief Summary
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Detailed Description
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The primary endpoints are:
1. the proportion of patients remaining free from atrial fibrillation, atrial flutter or atrial tachycardia (\> 2 minutes) recorded by the implantable cardiac monitor (Medtronic) at 24 months follow-up and
2. total atrial fibrillation burden recorded by the loop recorder.
Other endpoints:
1. Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
2. the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
3. prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
4. re-ablation after the index ablation procedure,
5. total procedural duration;
6. total time of fluoroscopy and radiation dose;
7. number and duration of cardiovascular hospitalization;
8. quality of life questionnaires at 12 months and 24 month compared with baseline,
9. cognitive function at 12 and 24 month compared with baseline,
10. cost-efficacy of the different ablation techniques.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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manual radiofrequency ablation
Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.
catheter ablation
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.
magnet navigation ablation
Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.
catheter ablation
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.
cryoablation
Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.
catheter ablation
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.
Interventions
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catheter ablation
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
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Heikki Huikuri
OTHER
Responsible Party
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Heikki Huikuri
Professor
Principal Investigators
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Heikki Huikuri, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oulu
Locations
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UOulu
Oulu, , Finland
Heikki Huikuri
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Heikki Huikuri, Prof
Role: primary
Pekka Raatikainen, prof
Role: backup
Heikki Huikuri, Prof
Role: primary
Related Links
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wep-page
Other Identifiers
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AFOulu
Identifier Type: -
Identifier Source: org_study_id