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ClinicalTrials.gov ID

NCT02639793

Lead Sponsor

Heikki HuikuriOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

300Estimated

Last Update Posted

Dec 28, 2015Estimated

Start Date

Jan 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Jan 2020Estimated

Official Title

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.

• Atrial Fibrillation

• catheter ablation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria:

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

Exclusion Criteria:

- Any contraindication to catheter ablation

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Heikki HuikuriOTHER

Collaborators

University of HelsinkiOTHER

heikki.huikuri@oiulu.fi+35883154108