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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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