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CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial (craft)

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ClinicalTrials.gov Identifier: NCT03716934
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nicasio Perez Castellano, Hospital San Carlos, Madrid

Brief Summary:

The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients.

The symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. Pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. Different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. Frequents monitoring periods provide the information of the heart rate and the effect of any intervention.

The "Confirm RX heart monitor® (Abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. This implantable Holter automatically detects and saves atrial and ventricular arrhythmic episodes. The device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options.

This is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the Arctic Front Advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Arctic Front Advance® balloon catheter Drug: Antiarrhythmic drug Device: Confirm RX heart monitor® (Abbott) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoablation
Cryoablation for bidirectional block of all pulmonary veins
Device: Arctic Front Advance® balloon catheter
Cryoablation of bidirectional block of all pulmonary veins

Device: Confirm RX heart monitor® (Abbott)
Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function

Active Comparator: Antiarrythmics
The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.
Drug: Antiarrhythmic drug
The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.

Device: Confirm RX heart monitor® (Abbott)
Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function




Primary Outcome Measures :
  1. Survival time with atrial fibrilation, auricular flutter or tachycardia [ Time Frame: Up to 9 months. ]
    Survival time without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes duration detected by Holter

  2. Presence of death or one major complications. [ Time Frame: first month ]
    Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.

  3. Presence of death or one major complications. [ Time Frame: fourth month ]
    Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.

  4. Presence of death or one major complications. [ Time Frame: thirteen month ]
    Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of VP, Sustained (> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.


Secondary Outcome Measures :
  1. Percentage of patients without atrial fibrilation, flutter or tachycardia [ Time Frame: first month ]
    Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes

  2. Percentage of patients without atrial fibrilation, flutter or tachycardia [ Time Frame: fourth month ]
    Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes

  3. Percentage of patients without atrial fibrilation, flutter or tachycardia [ Time Frame: thirteen month ]
    Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes

  4. Percentage of patient with cardioversion [ Time Frame: first month ]
    Number of patients that need cardioversion

  5. Percentage of patient with cardioversion [ Time Frame: fourth month ]
    Number of patients that need cardioversion

  6. Percentage of patient with cardioversion [ Time Frame: thirteen month ]
    Number of patients that need cardioversion

  7. Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events [ Time Frame: first month ]
    Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events

  8. Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events [ Time Frame: fourth month ]
    Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events

  9. Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events [ Time Frame: thirteen month ]
    Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events

  10. Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency [ Time Frame: first month ]
    Number of patients that need a change or suspension of antiarrhythmic due to inefficiency

  11. Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency [ Time Frame: fourth month ]
    Number of patients that need a change or suspension of antiarrhythmic due to inefficiency

  12. Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency [ Time Frame: thirteen month ]
    Number of patients that need a change or suspension of antiarrhythmic due to inefficiency

  13. Percentage of patient with need for ablation or re-ablation not scheduled [ Time Frame: first month ]
    Number of patients that need a ablation or re-ablation not scheduled

  14. Percentage of patient with need for ablation or re-ablation not scheduled [ Time Frame: fourth month ]
    Number of patients that need a ablation or re-ablation not scheduled

  15. Percentage of patient with need for ablation or re-ablation not scheduled [ Time Frame: thirteen month ]
    Number of patients that need a ablation or re-ablation not scheduled



Information from the National Library of Medicine

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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 recurrent persistent atrial fibrilation

Exclusion Criteria:

  • Patients with atrial fibrilation for more than one year at baseline
  • Atrial fibrilation prior ablation
  • Age> 75 years or <18 years
  • Hyperthyroidism
  • Hypertrophic cardiomyopathy
  • Severe valvular disease (stenosis or regurgitation)
  • Carriers of cardiac valves
  • Anteroposterior diameter of left atrium> 50 mm (left parasternal long axis)
  • Contraindications for anticoagulation
  • Left atrial thrombus
  • Anemia
  • Active infection
  • Pregnancy
  • Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)
  • Life expectancy of less than 24 months
  • Participation in another non-purely observational study
  • Patients unable to understand treatment and / or study and / or providing adequate informed consent
  • Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study
  • Microalbuminemia

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): NCT03716934


Contacts
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Contact: Perez Castellano +34913303000 ext 7278 nicasio.perez@salud.madrid.org

Locations
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Spain
Fundacion para Investigación Biomedica Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Ana Belen Rivas Paterna, PhD    +34913303000 ext 7360    fibucicec.hcsc@salud.madrid.org   
Sponsors and Collaborators
Hospital San Carlos, Madrid

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Responsible Party: Nicasio Perez Castellano, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03716934     History of Changes
Other Study ID Numbers: 17/507-R_M
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents