NCT02789358

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

A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation. Results of the the plusONE Randomized Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Conventional cryotherapy dosage	Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds
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
DEVICE	Arctic Front Advance ST Cryoenergy Balloon Catheter	Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon
DRUG	Adenosine triphosphate	12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected
DEVICE	nECG platform Nuubo®	30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2016-06-03
• Last updated: 2019-08-15

Locations

1 site across 1 country: Spain