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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: catheter ablation

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: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heikki Huikuri, Prof; Phone Number: +358400892330; Email: heikki.huikuri@oulu.fi
• Study Contact Backup: Name: Pekka Raatikainen, Prof; Phone Number: +35883154108; Email: pekka-raatikainen@hus.fi

Study Locations

• Finland
  • Oulu, Finland, 90014
    • UOulu
    • Contact: Heikki Huikuri, Prof; Phone Number: +35883155599; Email: heikki.huikuri@oulu.fi
    • Contact: Pekka Raatikainen, prof; Phone Number: +3588400892330; Email: pekka.raatikainen@hus.fi
  • Oulu, Finland
    • Heikki Huikuri
    • Contact: Heikki Huikuri, Prof; Phone Number: +35883154108; Email: heikki.huikuri@oiulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

Exclusion Criteria:

- Any contraindication to catheter ablation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total AF burden	total AF burden recorded by the implantable loop recorder during the 24 month follow-up.	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	24 months

Collaborators and Investigators

• Sponsor: Heikki Huikuri
• Collaborators: University of Helsinki
• Investigators: Principal Investigator: Heikki Huikuri, Prof, University of Oulu

Publications and helpful links

Helpful Links

• wep-page

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: arrhythmias, quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AFOulu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided