CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

Atrial Fibrillation Clinical Trial

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Official title:

CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716934
• Other study ID #: 17/507-R_M
• Status: Recruiting
• Phase: Phase 4
• Start date: June 27, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Hospital San Carlos, Madrid
• Contact: Perez Castellano
• Phone: +34913303000
• Email: nicasio.perez[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Arctic Front Advance® balloon catheter
Cryoablation of bidirectional block of all pulmonary veins

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

Locations

Country	Name	City	State
Spain	Fundacion para Investigación Biomedica Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of patient with cardioversion	Number of patients that need cardioversion	first month
Secondary	Percentage of patient with cardioversion	Number of patients that need cardioversion	fourth month
Secondary	Percentage of patient with cardioversion	Number of patients that need cardioversion	thirteen month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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