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This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Conventional protocol for cryoablation: At least 2 applications of 180s each |
|
| Study Arm | Experimental | Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional cryotherapy dosage | Other | Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation-free survival, without antiarrhythmic drug therapy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of cryotherapy applications per patient to complete isolation | Intraprocedural | |
| Total cryotherapy time | Total cryotherapy time of applications needed per patient | Intraprocedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ángel Ferrero De Loma-Osorio, MD, PhD | Cardiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29247029 | Derived | Ferrero-de-Loma-Osorio A, Garcia-Fernandez A, Castillo-Castillo J, Izquierdo-de-Francisco M, Ibanez-Criado A, Moreno-Arribas J, Martinez A, Bertomeu-Gonzalez V, Lopez-Mases P, Ajo-Ferrer M, Nunez C, Bondanza-Saavedra L, Sanchez-Gomez JM, Martinez-Martinez JG, Chorro-Gasco FJ, Ruiz-Granell R. Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005318. doi: 10.1161/CIRCEP.117.005318. |
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| Experimental cryotherapy dosage | Other | cryotherapy dosage: applications "time to block of the vein" plus 60 seconds long until block of the vein plus 1 bonus freezing of 120 seconds |
|
| Arctic Front Advance ST Cryoenergy Balloon Catheter | Device | Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon |
|
| Adenosine triphosphate | Drug | 12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected |
|
| nECG platform Nuubo® | Device | 30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation |
|
| Time required to complete isolation of all the pulmonary veins (LA time) | Time from the end of transeptal approach until the withdrawal of the cryoballoon | Intraprocedure |
| Total procedure time | Time from the local anesthesia is administrated until the whole procedure is finished | Intraprocedure |
| Acute reconnection of pulmonary veins | Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test | Intraprocedure |
| Adverse events | Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0 | Intraprocedure |
| Total number of atrial fibrillation episodes monitored by Nuubo system | 12 Months |
| Total time in atrial fibrillation monitored by Nuubo system | Total time in atrial fibrillation monitored by Nuubo system in hours | 12 months |
| Atrial fibrillation burden detected by Nuubo system | total time in atrial fibrillation related to the hole time of monitoring (percentage) | 12 Months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000255 | Adenosine Triphosphate |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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