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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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.
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:
Other endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual radiofrequency ablation | Active Comparator | Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique. |
|
| magnet navigation ablation | Active Comparator | Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique. |
|
| cryoablation | Active Comparator | Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter ablation | Procedure | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
- Any contraindication to catheter ablation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heikki Huikuri, Prof | Contact | +358400892330 | heikki.huikuri@oulu.fi | |
| Pekka Raatikainen, Prof | Contact | +35883154108 | pekka-raatikainen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Heikki Huikuri, Prof | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOulu | Oulu | 90014 | Finland |
|
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| 24 months |
| Heikki Huikuri | Oulu | Finland |
|
| D013514 |
| Surgical Procedures, Operative |