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

Atrial Fibrillation Clinical Trial

— MRICEMAN  

Official title:

A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02639793
• Other study ID #: AFOulu
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 9, 2015
• Last updated: December 24, 2015
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: December 2015
• Source: University of Oulu
• Contact: Heikki Huikuri, Prof
• Phone: +358400892330
• Email: heikki.huikuri[@]oulu.fi
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical 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 ablation using remote magnet monitoring, and cryoablation.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

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

Exclusion Criteria:

• Any contraindication to catheter ablation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Finland	Heikki Huikuri	Oulu
Finland	UOulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
Heikki Huikuri	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total AF burden	total AF burden recorded by the implantable loop recorder during the 24 month follow-up.	24 months	No
Secondary	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	Yes

External Links

•   wep-page