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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Arctic Front Advance® balloon catheter; Device: Confirm RX heart monitor® (Abbott); Drug: Antiarrhythmic drug

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 Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Perez Castellano; Phone Number: 7278 +34913303000; Email: nicasio.perez@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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; Drug: Antiarrhythmic drug; The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.; Other Names: Class I or III

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival time with atrial fibrilation, auricular flutter or tachycardia	Survival time without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes duration detected by Holter	Up to 9 months.
Presence of death or one major complications.	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.	first month
Presence of death or one major complications.	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.	fourth month
Presence of death or one major complications.	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.	thirteen month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients without atrial fibrilation, flutter or tachycardia	Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes	first month
Percentage of patients without atrial fibrilation, flutter or tachycardia	Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes	fourth month
Percentage of patients without atrial fibrilation, flutter or tachycardia	Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes	thirteen month
Percentage of patient with cardioversion	Number of patients that need cardioversion	first month
Percentage of patient with cardioversion	Number of patients that need cardioversion	fourth month
Percentage of patient with cardioversion	Number of patients that need cardioversion	thirteen month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events	Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events	first month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events	Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events	fourth month
Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events	Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events	thirteen month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency	Number of patients that need a change or suspension of antiarrhythmic due to inefficiency	first month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency	Number of patients that need a change or suspension of antiarrhythmic due to inefficiency	fourth month
Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency	Number of patients that need a change or suspension of antiarrhythmic due to inefficiency	thirteen month
Percentage of patient with need for ablation or re-ablation not scheduled	Number of patients that need a ablation or re-ablation not scheduled	first month
Percentage of patient with need for ablation or re-ablation not scheduled	Number of patients that need a ablation or re-ablation not scheduled	fourth month
Percentage of patient with need for ablation or re-ablation not scheduled	Number of patients that need a ablation or re-ablation not scheduled	thirteen month

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2018
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: 17/507-R_M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No