Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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:
-
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
-
total atrial fibrillation burden recorded by the loop recorder.
Other endpoints:
-
Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
-
the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
-
prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
-
re-ablation after the index ablation procedure,
-
total procedural duration;
-
total time of fluoroscopy and radiation dose;
-
number and duration of cardiovascular hospitalization;
-
quality of life questionnaires at 12 months and 24 month compared with baseline,
-
cognitive function at 12 and 24 month compared with baseline,
-
cost-efficacy of the different ablation techniques.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Free of atrial fibrillation [24 months]
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.
Secondary Outcome Measures
- Total AF burden [24 months]
total AF burden recorded by the implantable loop recorder during the 24 month follow-up.
- Incidence of adverse events [24 months]
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
Eligibility Criteria
Criteria
Inclusion criteria:
- Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation
Exclusion Criteria:
- Any contraindication to catheter ablation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UOulu | Oulu | Finland | 90014 | |
| 2 | Heikki Huikuri | Oulu | Finland |
Sponsors and Collaborators
- Heikki Huikuri
- University of Helsinki
Investigators
- Principal Investigator: Heikki Huikuri, Prof, University of Oulu
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- AFOulu