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

Atrial Fibrillation Clinical Trial

— plusONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789358
• Other study ID #: FIHCValencia
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2019
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation-free survival, without antiarrhythmic drug therapy		12 months
Secondary	Mean number of cryotherapy applications per patient to complete isolation		Intraprocedural
Secondary	Total cryotherapy time	Total cryotherapy time of applications needed per patient	Intraprocedure
Secondary	Time required to complete isolation of all the pulmonary veins (LA time)	Time from the end of transeptal approach until the withdrawal of the cryoballoon	Intraprocedure
Secondary	Total procedure time	Time from the local anesthesia is administrated until the whole procedure is finished	Intraprocedure
Secondary	Acute reconnection of pulmonary veins	Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test	Intraprocedure
Secondary	Adverse events	Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0	Intraprocedure
Secondary	Total number of atrial fibrillation episodes monitored by Nuubo system		12 Months
Secondary	Total time in atrial fibrillation monitored by Nuubo system	Total time in atrial fibrillation monitored by Nuubo system in hours	12 months
Secondary	Atrial fibrillation burden detected by Nuubo system	total time in atrial fibrillation related to the hole time of monitoring (percentage)	12 Months