Clinical trial NCT02789358: A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: cryotherapy
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Atrial fibrillation-free survival, without antiarrhythmic drug therapy
timeFrame: 12 months
Secondary outcomes:
measure: Mean number of cryotherapy applications per patient to complete isolation
timeFrame: Intraprocedural
measure: Total cryotherapy time
timeFrame: Intraprocedure
measure: Time required to complete isolation of all the pulmonary veins (LA time)
timeFrame: Intraprocedure
measure: Total procedure time
timeFrame: Intraprocedure
measure: Acute reconnection of pulmonary veins
timeFrame: Intraprocedure
measure: Adverse events
timeFrame: Intraprocedure
measure: Total number of atrial fibrillation episodes monitored by Nuubo system
timeFrame: 12 Months
measure: Total time in atrial fibrillation monitored by Nuubo system
timeFrame: 12 months
measure: Atrial fibrillation burden detected by Nuubo system
timeFrame: 12 Months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Cardiologist
name: Ángel Ferrero De Loma-Osorio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrero-de-Loma-Osorio A, Garcia-Fernandez A, Castillo-Castillo J, Izquierdo-de-Francisco M, Ibanez-Criado A, Moreno-Arribas J, Martinez A, Bertomeu-Gonzalez V, Lopez-Mases P, Ajo-Ferrer M, Nunez C, Bondanza-Saavedra L, Sanchez-Gomez JM, Martinez-Martinez JG, Chorro-Gasco FJ, Ruiz-Granell R. Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005318. doi: 10.1161/CIRCEP.117.005318.