Atrial FibrillationplusONENCT02789358
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
A study testing Conventional cryotherapy dosage, Experimental cryotherapy dosage and Arctic Front Advance ST Cryoenergy Balloon Catheter in people with Atrial Fibrillation, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Conventional cryotherapy dosage, Experimental cryotherapy dosage and Arctic Front Advance ST Cryoenergy Balloon Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Conventional cryotherapy dosage, Experimental cryotherapy dosage, Arctic Front Advance ST Cryoenergy Balloon Catheter, Adenosine triphosphate, nECG platform Nuubo®
- Keywords
- cryotherapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cryotherapy dosageOther
Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds
Experimental cryotherapy dosageOther
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
Arctic Front Advance ST Cryoenergy Balloon CatheterDevice
Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon
Adenosine triphosphateDrug
12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected
nECG platform Nuubo®Device
30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Conventional protocol for cryoablation:
At least 2 applications of 180s each Receives: 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 Receives: Other: Experimental cryotherapy dosage; Device: Arctic Front Advance ST Cryoenergy Balloon Catheter; Drug: Adenosine triphosphate; Device: nECG platform Nuubo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
Measured: 12 months
Secondary outcomes (9)
Mean number of cryotherapy applications per patient to complete isolation
Measured: Intraprocedural
Total cryotherapy time
Total cryotherapy time of applications needed per patient
Measured: Intraprocedure
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
Measured: Intraprocedure
Total procedure time
Time from the local anesthesia is administrated until the whole procedure is finished
Measured: Intraprocedure
Acute reconnection of pulmonary veins
Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test
Measured: Intraprocedure
Adverse events
Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0
Measured: Intraprocedure
Total number of atrial fibrillation episodes monitored by Nuubo system
Measured: 12 Months
Total time in atrial fibrillation monitored by Nuubo system
Total time in atrial fibrillation monitored by Nuubo system in hours
Measured: 12 months
Atrial fibrillation burden detected by Nuubo system
total time in atrial fibrillation related to the hole time of monitoring (percentage)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Ferrero, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Ángel Ferrero De Loma-Osorio, MD, PhD, Principal investigator, Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789358
- Sponsor's protocol ID
- FIHCValencia
- Acronym
- plusONE
- Status last verified
- Aug 2019
- First submitted
- 17 May 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29247029
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02789358
- Acronym / sponsor ID
- plusONE / FIHCValencia
- Conditions
- Atrial Fibrillation
- Keywords
- cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Conventional cryotherapy dosage, Device: Arctic Front Advance ST Cryoenergy Balloon Catheter, Drug: Adenosine triphosphate, Device: nECG platform Nuubo®Conventional protocol for cryoablation: At least 2 applications of 180s each |
| Study Arm | Experimental | Other: Experimental cryotherapy dosage, Device: Arctic Front Advance ST Cryoenergy Balloon Catheter, Drug: Adenosine triphosphate, Device: nECG platform Nuubo®Experimental protocol for cryoablation: Time to effect + 1 minute and a bonus application of 120s |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with at least 2 documented episodes of paroxysmal Atrial Fibrillation (AF) which are not responders to at least one antiarrythmic drug
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional cryotherapy dosageCryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds | Other | Control Arm |
| Experimental cryotherapy dosagecryotherapy dosage: applications "time to block of the vein" plus 60 seconds long until block of the vein plus 1 bonus freezing of 120 seconds | Other | Study Arm |
| Arctic Front Advance ST Cryoenergy Balloon CatheterElectrical isolation of pulmonary veins with Arctic Front Advance cryoballoon | Device | Control Arm, Study Arm |
| Adenosine triphosphate12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected | Drug | Control Arm, Study Arm |
| nECG platform Nuubo®30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation | Device | Control Arm, Study Arm |
Primary outcome
Atrial fibrillation-free survival, without antiarrhythmic drug therapy
Time frame: 12 months
9 secondary outcomes
Mean number of cryotherapy applications per patient to complete isolation
Time frame: Intraprocedural
Total cryotherapy time
Time frame: Intraprocedure
Time required to complete isolation of all the pulmonary veins (LA time)
Time frame: Intraprocedure
Total procedure time
Time frame: Intraprocedure
Acute reconnection of pulmonary veins
Time frame: Intraprocedure
Adverse events
Time frame: Intraprocedure
Total number of atrial fibrillation episodes monitored by Nuubo system
Time frame: 12 Months
Total time in atrial fibrillation monitored by Nuubo system
Time frame: 12 months
Atrial fibrillation burden detected by Nuubo system
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 29247029Ferrero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángel Ferrero De Loma-Osorio, MD, PhD principal investigator
Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cryotherapy dosage, Experimental cryotherapy dosage and Arctic Front Advance ST Cryoenergy Balloon Catheter in people with Atrial Fibrillation, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation-free survival, without antiarrhythmic drug therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.