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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Adenosine triphosphate; Other: Conventional cryotherapy dosage; Device: Arctic Front Advance ST Cryoenergy Balloon Catheter; Device: nECG platform Nuubo®; Other: Experimental cryotherapy dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT02789358

FIHCValencia

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Conventional protocol for cryoablation: At least 2 applications of 180s each

Treatment:

Drug: Adenosine triphosphate

Device: nECG platform Nuubo®

Device: Arctic Front Advance ST Cryoenergy Balloon Catheter

Other: Conventional cryotherapy dosage

Study Arm

Experimental group

Description:

Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s

Treatment:

Drug: Adenosine triphosphate

Other: Experimental cryotherapy dosage

Device: nECG platform Nuubo®

Device: Arctic Front Advance ST Cryoenergy Balloon Catheter