A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation

Fundación para la Investigación del Hospital Clínico de Valencia140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Atrial Fibrillation

Interventions

Conventional cryotherapy dosageOTHER

Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds

Experimental cryotherapy dosageOTHER

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 CatheterDEVICE

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clínico Universitario de Valencia

Valencia, Spain

Outcomes

Primary Outcomes

Atrial fibrillation-free survival, without antiarrhythmic drug therapy

Time frame: 12 months

Secondary Outcomes

Mean number of cryotherapy applications per patient to complete isolation

Time frame: Intraprocedural

Total cryotherapy time

Total cryotherapy time of applications needed per patient

Time frame: Intraprocedure

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

Time frame: Intraprocedure

Total procedure time

Time from the local anesthesia is administrated until the whole procedure is finished

Time frame: 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

Time frame: Intraprocedure

Adverse events

Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0

Time frame: Intraprocedure

Total number of atrial fibrillation episodes monitored by Nuubo system

Time frame: 12 Months

Total time in atrial fibrillation monitored by Nuubo system

Data from ClinicalTrials.gov

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