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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional cryotherapy dosage
Experimental cryotherapy dosage
Arctic Front Advance ST Cryoenergy Balloon Catheter
Adenosine triphosphate
nECG platform Nuubo®
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring cryotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Study Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Atrial fibrillation-free survival, without antiarrhythmic drug therapy

Secondary Outcome Measures

Mean number of cryotherapy applications per patient to complete isolation
Total cryotherapy time
Total cryotherapy time of applications needed per patient
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
Total procedure time
Time from the local anesthesia is administrated until the whole procedure is finished
Acute reconnection of pulmonary veins
Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test
Adverse events
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
Total time in atrial fibrillation monitored by Nuubo system
Total time in atrial fibrillation monitored by Nuubo system in hours
Atrial fibrillation burden detected by Nuubo system
total time in atrial fibrillation related to the hole time of monitoring (percentage)

Full Information

First Posted
May 17, 2016
Last Updated
August 14, 2019
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02789358
Brief Title
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Conventional protocol for cryoablation: At least 2 applications of 180s each
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s
Intervention Type
Other
Intervention Name(s)
Conventional cryotherapy dosage
Intervention Description
Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds
Intervention Type
Other
Intervention Name(s)
Experimental cryotherapy dosage
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Arctic Front Advance ST Cryoenergy Balloon Catheter
Intervention Description
Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon
Intervention Type
Drug
Intervention Name(s)
Adenosine triphosphate
Intervention Description
12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected
Intervention Type
Device
Intervention Name(s)
nECG platform Nuubo®
Intervention Description
30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation
Primary Outcome Measure Information:
Title
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean number of cryotherapy applications per patient to complete isolation
Time Frame
Intraprocedural
Title
Total cryotherapy time
Description
Total cryotherapy time of applications needed per patient
Time Frame
Intraprocedure
Title
Time required to complete isolation of all the pulmonary veins (LA time)
Description
Time from the end of transeptal approach until the withdrawal of the cryoballoon
Time Frame
Intraprocedure
Title
Total procedure time
Description
Time from the local anesthesia is administrated until the whole procedure is finished
Time Frame
Intraprocedure
Title
Acute reconnection of pulmonary veins
Description
Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test
Time Frame
Intraprocedure
Title
Adverse events
Description
Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0
Time Frame
Intraprocedure
Title
Total number of atrial fibrillation episodes monitored by Nuubo system
Time Frame
12 Months
Title
Total time in atrial fibrillation monitored by Nuubo system
Description
Total time in atrial fibrillation monitored by Nuubo system in hours
Time Frame
12 months
Title
Atrial fibrillation burden detected by Nuubo system
Description
total time in atrial fibrillation related to the hole time of monitoring (percentage)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ángel Ferrero De Loma-Osorio, MD, PhD
Organizational Affiliation
Cardiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29247029
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.
Results Reference
derived

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

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