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| Name | Class |
|---|---|
| Medtronic International Trading Sarl | INDUSTRY |
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The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation.
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. It is estimated that more than 7 million people worldwide have the disease. Over the past decade, catheter ablation has become an accepted treatment for patients with AF. Ablation strategies that target the pulmonary vein are considered the cornerstone for treatment. The innovative Arctic Front cryoballoon is used for the treatment of drug refractory recurrent symptomatic paroxysmal AF (PAF). The system was designed to overcome many of the challenges of point-by-point catheter ablation by providing an anatomical approach for pulmonary vein isolation (PVI), creating long contiguous circumferential lesions surrounding the pulmonary vein. The cryoballoon system has a low risk of complications and proven efficacy in treating PAF.
AF recurrence rates have been reported up to 30% after initial ablation with PVI technologies including point-by-point RF catheter ablation. Arrhythmia recurrence can be caused by non-contiguous ablation lines that allow conduction gaps. Arctic Front Advanceâ„¢ Cardiac CryoAblation Catheter (Arctic Front Advance), the second-generation cryoballoon which has recently been introduced following clearance by regulatory agencies in both the US and EU, is positioned to address this challenge with PVI technologies. The new catheter features the EvenCoolâ„¢ Cryo Technology, which optimizes how the refrigerant is distributed inside the balloon, providing more uniform, distal cooling around the circumference of the balloon. The purpose of this study is to examine the rate of electrical PV isolation with the next generation system .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | Ablation with Arctic Front Advance Cardiac CryoAblation system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Front Advance Cardiac CryoAblation system | Device | Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system |
| Measure | Description | Time Frame |
|---|---|---|
| electrical pulmonary vein isolation | Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment | approximately 3 months postablation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical AF recurrence | ECG-documented clinical AF recurrence will be measured by ambulatory monitoring approximately 3 months post-treatment | approximately 3 months post-ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Y. Reddy | Nemocnice Na Homolce | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homolka Hospital | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20132391 | Background | Ahmed H, Neuzil P, Skoda J, D'Avila A, Donaldson DM, Laragy MC, Reddy VY. The permanency of pulmonary vein isolation using a balloon cryoablation catheter. J Cardiovasc Electrophysiol. 2010 Jul;21(7):731-7. doi: 10.1111/j.1540-8167.2009.01703.x. Epub 2010 Feb 1. | |
| 25644659 | Derived | Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500. doi: 10.1111/jce.12626. Epub 2015 Apr 15. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |