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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Arm

Conventional protocol for cryoablation:

At least 2 applications of 180s each

Group Type ACTIVE_COMPARATOR

Conventional cryotherapy dosage

Intervention Type OTHER

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

Arctic Front Advance ST Cryoenergy Balloon Catheter

Intervention Type DEVICE

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Adenosine triphosphate

Intervention Type DRUG

12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected

nECG platform Nuubo®

Intervention Type DEVICE

30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation

Study Arm

Experimental protocol for cryoablation:

Time to effect + 1 minute and a bonus application of 120s

Group Type EXPERIMENTAL

Experimental cryotherapy dosage

Intervention Type 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

Intervention Type DEVICE

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Adenosine triphosphate

Intervention Type DRUG

12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected

nECG platform Nuubo®

Intervention Type DEVICE

30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation

Interventions

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Conventional cryotherapy dosage

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

Intervention Type OTHER

Experimental 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

Intervention Type OTHER

Arctic Front Advance ST Cryoenergy Balloon Catheter

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Intervention Type DEVICE

Adenosine triphosphate

12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected

Intervention Type DRUG

nECG platform Nuubo®

30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No