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

NCT02789358 | Completed

• 1 other identifier: FIHCValencia
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

cryotherapy

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation-free survival, without antiarrhythmic drug therapy

  12 months

Secondary Outcomes (9)

• Mean number of cryotherapy applications per patient to complete isolation

  Intraprocedural

• Total cryotherapy time

  Intraprocedure

• Time required to complete isolation of all the pulmonary veins (LA time)

  Intraprocedure

• Total procedure time

  Intraprocedure

• Acute reconnection of pulmonary veins

  Intraprocedure

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Conventional protocol for cryoablation: At least 2 applications of 180s each

Other: Conventional cryotherapy dosage; Device: Arctic Front Advance ST Cryoenergy Balloon Catheter; Drug: Adenosine triphosphate; Device: nECG platform Nuubo®

Study Arm

EXPERIMENTAL

Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s

Other: Experimental cryotherapy dosage; Device: Arctic Front Advance ST Cryoenergy Balloon Catheter; Drug: Adenosine triphosphate; Device: nECG platform Nuubo®

Interventions

Conventional cryotherapy dosage OTHER

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

Control Arm

Experimental cryotherapy dosage OTHER

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

Study Arm

Arctic Front Advance ST Cryoenergy Balloon Catheter DEVICE

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Control Arm; Study Arm

Adenosine triphosphate DRUG

12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected

Control Arm; Study Arm

nECG platform Nuubo® DEVICE

30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation

Control Arm; Study Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 29247029 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Adenosine Triphosphate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ángel Ferrero De Loma-Osorio, MD, PhD

  Cardiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 3, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)