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Completed

NCT Number: NCT02789358

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional cryotherapy dosage

Other

Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds

Experimental cryotherapy dosage

Other

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 Catheter

Device

Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon

Adenosine triphosphate

Drug

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

Primary outcomes

  1. Atrial fibrillation-free survival, without antiarrhythmic drug therapy

    Time frame: 12 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study 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

Acronym: plusONE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2016
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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