Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 9, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date December 28, 2015
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Total AF burden [ Time Frame: 24 months ]
    total AF burden recorded by the implantable loop recorder during the 24 month follow-up.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
Official Title  ICMJE A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: manual radiofrequency ablation
    Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.
    Intervention: Procedure: catheter ablation
  • Active Comparator: magnet navigation ablation
    Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.
    Intervention: Procedure: catheter ablation
  • Active Comparator: cryoablation
    Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.
    Intervention: Procedure: catheter ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

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

Exclusion Criteria:

- Any contraindication to catheter ablation

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639793
Other Study ID Numbers  ICMJE AFOulu
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Heikki Huikuri, University of Oulu
Study Sponsor  ICMJE Heikki Huikuri
Collaborators  ICMJE University of Helsinki
Investigators  ICMJE
Principal Investigator: Heikki Huikuri, Prof University of Oulu
PRS Account University of Oulu
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP