NL-OMON42900
Completed
Not Applicable
Catheter Cryoablation versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation - CRYO-FIRST
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic B.V.
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above and at least two symptomatic episodes in the last six months prior to inclusion.
- •\* At least one episode of AF must be documented during the prior year by any kind of ECG recording.
- •\* Subject has structural normal heart with an LVEF \* 50%, thickness of the inter\-ventricular septum \*12 mm and left atrium diameters (short axis) \< 46 mm obtained by transthoracic echocardiography.
- •\* Subject has normal ECG parameters (QRS width in the 12 channel surface ECG \*120 ms, QTc \* interval \< 440 ms, PQ \* interval \* 210 ms; all parameters should be measured at sinus rhythm).
- •\* Subject is at least 18 and \* 75years old.
- •\* Subject is able and willing to give informed consent.
Exclusion Criteria
- •\* Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration \>7 days).
- •\* Subject has documented typical atrial flutter.
- •\* Subject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.
- •\* Subject had any previous left atrial ablation.
- •\* Subject had any previous cardiac surgery, e.g. prosthetic valves.
- •\* Subject has permanent pacemaker or defibrillator implant.
- •\* Subject has 2° type II, 3° degree AV\-block or left/right bundle branch block pattern.
- •\* Subject has unstable angina pectoris.
- •\* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
- •\* Subject has symptomatic carotid stenosis.
Outcomes
Primary Outcomes
Not specified
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