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Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN) (MRICEMAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639793
Recruitment Status : Unknown
Verified December 2015 by Heikki Huikuri, University of Oulu.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2015
Last Update Posted : December 28, 2015
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Heikki Huikuri, University of Oulu

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: catheter ablation Phase 4

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: manual radiofrequency ablation
Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.
Procedure: 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.

Active Comparator: magnet navigation ablation
Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.
Procedure: 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.

Active Comparator: cryoablation
Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.
Procedure: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total AF burden [ Time Frame: 24 months ]
    total AF burden recorded by the implantable loop recorder during the 24 month follow-up.

  2. Incidence of adverse events [ Time Frame: 24 months ]

    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




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation

Exclusion Criteria:

- Any contraindication to catheter ablation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639793


Contacts
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Contact: Heikki Huikuri, Prof +358400892330 heikki.huikuri@oulu.fi
Contact: Pekka Raatikainen, Prof +35883154108 pekka-raatikainen@hus.fi

Locations
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Finland
UOulu
Oulu, Finland, 90014
Contact: Heikki Huikuri, Prof    +35883155599    heikki.huikuri@oulu.fi   
Contact: Pekka Raatikainen, prof    +3588400892330    pekka.raatikainen@hus.fi   
Heikki Huikuri
Oulu, Finland
Contact: Heikki Huikuri, Prof    +35883154108    heikki.huikuri@oiulu.fi   
Sponsors and Collaborators
Heikki Huikuri
University of Helsinki
Investigators
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Principal Investigator: Heikki Huikuri, Prof University of Oulu
Additional Information:
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Responsible Party: Heikki Huikuri, Professor, University of Oulu
ClinicalTrials.gov Identifier: NCT02639793    
Other Study ID Numbers: AFOulu
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heikki Huikuri, University of Oulu:
arrhythmias, quality of life
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes