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

Heikki Huikuri

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02639793

AFOulu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any contraindication to catheter ablation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

manual radiofrequency ablation

Active Comparator group

Description:

Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.

Treatment:

Procedure: catheter ablation

magnet navigation ablation

Active Comparator group

Description:

Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.

Treatment:

Procedure: catheter ablation

cryoablation

Active Comparator group

Description:

Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.

Treatment:

Procedure: catheter ablation