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

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Completed
CT.gov ID
NCT02789358
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
8
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional cryotherapy dosage
  • Other: Experimental cryotherapy dosage
  • Device: Arctic Front Advance ST Cryoenergy Balloon Catheter
  • Drug: Adenosine triphosphate
  • Device: nECG platform Nuubo®
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 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 :
Dec 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Atrial fibrillation-free survival, without antiarrhythmic drug therapy [12 months]

Secondary Outcome Measures

  1. Mean number of cryotherapy applications per patient to complete isolation [Intraprocedural]

  2. Total cryotherapy time [Intraprocedure]

    Total cryotherapy time of applications needed per patient

  3. Time required to complete isolation of all the pulmonary veins (LA time) [Intraprocedure]

    Time from the end of transeptal approach until the withdrawal of the cryoballoon

  4. Total procedure time [Intraprocedure]

    Time from the local anesthesia is administrated until the whole procedure is finished

  5. Acute reconnection of pulmonary veins [Intraprocedure]

    Number of veins reconnected after a 30 minutes waiting period since the end of procedure and with adenosine test

  6. Adverse events [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 [12 Months]

  8. Total time in atrial fibrillation monitored by Nuubo system [12 months]

    Total time in atrial fibrillation monitored by Nuubo system in hours

  9. Atrial fibrillation burden detected by Nuubo system [12 Months]

    total time in atrial fibrillation related to the hole time of monitoring (percentage)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clínico Universitario de Valencia Valencia Spain 46010

Sponsors and Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angel Ferrero, MD-PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT02789358
Other Study ID Numbers:
  • FIHCValencia
First Posted:
Jun 3, 2016
Last Update Posted:
Aug 15, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Angel Ferrero, MD-PhD, Fundación para la Investigación del Hospital Clínico de Valencia
cryotherapy
Additional relevant MeSH terms:
Atrial Fibrillation
Adenosine

Study Results

No Results Posted as of Aug 15, 2019