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

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ClinicalTrials.gov Identifier: NCT02789358
Recruitment Status : Unknown
Verified August 2016 by Angel Ferrero, Fundación para la Investigación del Hospital Clínico de Valencia.
Recruitment status was:  Recruiting
First Posted : June 3, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Angel Ferrero, Fundación para la Investigación del Hospital Clínico de Valencia

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Conventional cryotherapy dosage Other: Experimental cryotherapy dosage Device: Arctic Front Advance ST Cryoenergy Balloon Catheter Drug: Adenosine triphosphate Device: nECG platform Nuubo® Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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

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

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




Primary Outcome Measures :
  1. Atrial fibrillation-free survival, without antiarrhythmic drug therapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean number of cryotherapy applications per patient to complete isolation [ Time Frame: Intraprocedural ]
  2. Total cryotherapy time [ Time Frame: Intraprocedure ]
    Total cryotherapy time of applications needed per patient

  3. 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

  4. Total procedure time [ Time Frame: Intraprocedure ]
    Time from the local anesthesia is administrated until the whole procedure is finished

  5. 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

  6. Adverse events [ Time Frame: Intraprocedure ]
    Number of participants with procedural-related adverse events as assessed by by CTCAE v4.0

  7. Total number of atrial fibrillation episodes monitored by Nuubo system [ Time Frame: 12 Months ]
  8. Total time in atrial fibrillation monitored by Nuubo system [ Time Frame: 12 months ]
    Total time in atrial fibrillation monitored by Nuubo system in hours

  9. Atrial fibrillation burden detected by Nuubo system [ Time Frame: 12 Months ]
    total time in atrial fibrillation related to the hole time of monitoring (percentage)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789358


Contacts
Contact: Ángel Ferrero De Loma-Osorio, MD, PhD 0034 96 1973806 angelferrero@hotmail.com
Contact: Ricardo Ruiz Granell, Md, PhD 0034 96 1973806 ricardo.ruizgranell@gmail.com

Locations
Spain
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Ángel Ferrero De Loma-Osorio, PhD MD    +341973977    angelferrero@hotmail.com   
Contact: Marta Peiró, PhD    +341973536    mpeiro@incliva.es   
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
Principal Investigator: Ángel Ferrero De Loma-Osorio, MD, PhD Cardiologist

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Angel Ferrero, MD-PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT02789358     History of Changes
Other Study ID Numbers: FIHCValencia
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Angel Ferrero, Fundación para la Investigación del Hospital Clínico de Valencia:
cryotherapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action