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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Conventional cryotherapy dosage; Other: Experimental cryotherapy dosage; Device: Arctic Front Advance ST Cryoenergy Balloon Catheter; Drug: Adenosine triphosphate; Device: nECG platform Nuubo®

• Registration Number: NCT02789358
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-05-17
• Primary Completion: 2016-06
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-03
• Study Completion: 2016-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Arctic Front Advance ST Cryoenergy Balloon Catheter	Conventional protocol for cryoablation: At least 2 applications of 180s each
Control Arm	Conventional cryotherapy dosage	Conventional protocol for cryoablation: At least 2 applications of 180s each
Control Arm	nECG platform Nuubo®	Conventional protocol for cryoablation: At least 2 applications of 180s each
Study Arm	Experimental cryotherapy dosage	Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s
Study Arm	Arctic Front Advance ST Cryoenergy Balloon Catheter	Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s
Study Arm	nECG platform Nuubo®	Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s
Control Arm	Adenosine triphosphate	Conventional protocol for cryoablation: At least 2 applications of 180s each
Study Arm	Adenosine triphosphate	Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation-free survival, without antiarrhythmic drug therapy	12 months

Secondary Outcome Measures

Name	Time	Method
Total cryotherapy time	Intraprocedure	Total cryotherapy time of applications needed per patient
Total procedure time	Intraprocedure	Time from the local anesthesia is administrated until the whole procedure is finished
Acute reconnection of pulmonary veins	Intraprocedure	Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test
Time required to complete isolation of all the pulmonary veins (LA time)	Intraprocedure	Time from the end of transeptal approach until the withdrawal of the cryoballoon
Mean number of cryotherapy applications per patient to complete isolation	Intraprocedural
Atrial fibrillation burden detected by Nuubo system	12 Months	total time in atrial fibrillation related to the hole time of monitoring (percentage)
Adverse events	Intraprocedure	Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0
Total number of atrial fibrillation episodes monitored by Nuubo system	12 Months
Total time in atrial fibrillation monitored by Nuubo system	12 months	Total time in atrial fibrillation monitored by Nuubo system in hours

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain