Atrial Fibrillation
Conditions
Keywords
cryotherapy
Brief summary
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.
Interventions
OTHERConventional cryotherapy dosage
Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds
OTHERExperimental cryotherapy dosage
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
DEVICEArctic Front Advance ST Cryoenergy Balloon Catheter
Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon
12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected
DEVICEnECG platform Nuubo®
30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug
Exclusion criteria
* Previous left atrial ablation procedure or surgery * left atrium diameter \> 50mm * presence of intracardiac thrombus * Left ventricular ejection fraction \< 40% * Heart failure class III-IV * Severe valvulopathies * Acute coronary syndrome or cardiac surgery within the previous 3 months of enrollment * Transient ischemic attack/stroke within the previous 6 months of enrollment * life expectancy less than 1 year * Any contraindication to the procedure according to the current clinical practice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation-free survival, without antiarrhythmic drug therapy | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of cryotherapy applications per patient to complete isolation | Intraprocedural | — |
| Total cryotherapy time | Intraprocedure | Total cryotherapy time of applications needed per patient |
| Time required to complete isolation of all the pulmonary veins (LA time) | Intraprocedure | Time from the end of transeptal approach until the withdrawal of the cryoballoon |
| Total procedure time | Intraprocedure | Time from the local anesthesia is administrated until the whole procedure is finished |
| Acute reconnection of pulmonary veins | Intraprocedure | Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test |
| Adverse events | Intraprocedure | Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0 |
| Total number of atrial fibrillation episodes monitored by Nuubo system | 12 Months | — |
| Total time in atrial fibrillation monitored by Nuubo system | 12 months | Total time in atrial fibrillation monitored by Nuubo system in hours |
| Atrial fibrillation burden detected by Nuubo system | 12 Months | total time in atrial fibrillation related to the hole time of monitoring (percentage) |
Countries
Spain
Outcome results
None listed