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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Treatments: Adenosine

Criteria

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