Atrial FibrillationPhase 4MRICEMANNCT02639793
Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
A Phase 4 study testing catheter ablation in people with Atrial Fibrillation, run by Heikki Huikuri at 2 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFinland
- Study dates
- Jan 2016to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation
Who cannot join
- Any contraindication to catheter ablation
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
UOulu
Oulu, 90014
Heikki Huikuri, Prof, +35883155599, heikki.huikuri@oulu.fi
Pekka Raatikainen, prof, +3588400892330, pekka.raatikainen@hus.fi
Heikki Huikuri
Oulu
Heikki Huikuri, Prof, +35883154108, heikki.huikuri@oiulu.fi
About this study
Official title: A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
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.
Read the detailed description
A total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. A loop recorder (REVEAL) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period.
The primary endpoints are:
- 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
- total atrial fibrillation burden recorded by the loop recorder.
Other endpoints:
- Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
- the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
- prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
- re-ablation after the index ablation procedure,
- total procedural duration;
- total time of fluoroscopy and radiation dose;
- number and duration of cardiovascular hospitalization;
- quality of life questionnaires at 12 months and 24 month compared with baseline,
- cognitive function at 12 and 24 month compared with baseline,
- cost-efficacy of the different ablation techniques.
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation
- Keywords
- arrhythmias, quality of life
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| manual radiofrequency ablation | Active comparator | Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique. Receives: Procedure: catheter ablation |
| magnet navigation ablation | Active comparator | Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique. Receives: Procedure: catheter ablation |
| cryoablation | Active comparator | Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation. Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Total AF burden
total AF burden recorded by the implantable loop recorder during the 24 month follow-up.
Measured: 24 months
Incidence of adverse events
Safety is one of the secondary endpoints. The following potential adverse events will be monitored: Any previous left atrial ablation or surgery Any cardiac surgery or percutaneous coronary intervention within three months prior to enrolment.
Secondary AF Stroke or transient ischemic attack within six months prior to enrolment Myocardial infarction within three months prior to enrolment Left ventricular ejection fraction < 40 % Anteroposterior left atrial diameter >55 mm by transthoracic or transesophageal echocardiography Implanted prosthetic valve
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heikki Huikuri
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor-investigator, Heikki Huikuri, University of Oulu
- Investigators
- Heikki Huikuri, Prof, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639793
- Sponsor's protocol ID
- AFOulu
- Acronym
- MRICEMAN
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
- ClinicalTrials.gov ID
- NCT02639793
- Acronym / sponsor ID
- MRICEMAN / AFOulu
- Conditions
- Atrial Fibrillation
- Keywords
- arrhythmias, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heikki HuikuriUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. A loop recorder (REVEAL) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period.
The primary endpoints are:
- 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
- total atrial fibrillation burden recorded by the loop recorder.
Other endpoints:
- Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
- the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
- prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
- re-ablation after the index ablation procedure,
- total procedural duration;
- total time of fluoroscopy and radiation dose;
- number and duration of cardiovascular hospitalization;
- quality of life questionnaires at 12 months and 24 month compared with baseline,
- cognitive function at 12 and 24 month compared with baseline,
- cost-efficacy of the different ablation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| manual radiofrequency ablation | Active comparator | Procedure: catheter ablationRadiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique. |
| magnet navigation ablation | Active comparator | Procedure: catheter ablationRadiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique. |
| cryoablation | Active comparator | Procedure: catheter ablationCatheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation
Key exclusion criteria (1 listed)
- Any contraindication to catheter ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter ablationThree 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. | Procedure or surgery | cryoablation, magnet navigation ablation, manual radiofrequency ablation |
Primary outcome
Free of atrial fibrillation
Time frame: 24 months
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.
2 secondary outcomes
Total AF burden
Time frame: 24 months
Incidence of adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- wep-pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki Huikuri, Prof principal investigator
University of Oulu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing catheter ablation in people with Atrial Fibrillation, run by Heikki Huikuri at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heikki Huikuri, Prof (+358400892330, heikki.huikuri@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free of atrial fibrillation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.