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

August 14, 2019 updated by: Angel Ferrero, Fundación para la Investigación del Hospital Clínico de Valencia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm

Conventional protocol for cryoablation:

At least 2 applications of 180s each
Other: Conventional cryotherapy dosage
Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 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
Experimental: Study Arm

Experimental protocol for cryoablation:

Time to effect + 1 minute and a bonus application of 120s
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

  • Principal Investigator: Ángel Ferrero De Loma-Osorio, MD, PhD, Cardiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIHCValencia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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