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

• ClinicalTrials.gov Identifier: NCT03716934
• Recruitment Status: Recruiting
• First Posted: October 23, 2018
• Last Update Posted: February 7, 2022
• Sponsor: Hospital San Carlos, Madrid
• Information provided by (Responsible Party): Nicasio Perez Castellano, Hospital San Carlos, Madrid

Study Description

Brief Summary:

This is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of PVs using the Arctic Front Advance® balloon catheter with antiarrhythmic therapy in patients with persistent AF.

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

Detailed Description:

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.

Study Design

• 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 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

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.; Other Name: Class I or III; 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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

More Information

• Responsible Party: Nicasio Perez Castellano, Principal Investigator, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT03716934
• Other Study ID Numbers: 17/507-R_M
• First Posted: October 23, 2018
• Last Update Posted: February 7, 2022
• Last Verified: January 2022

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

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Anti-Arrhythmia Agents