CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

NCT03716934 | Completed Phase 4 DMC

• 1 other identifier: 17/507-R_M
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• Percentage of patients without atrial fibrilation, flutter or tachycardia

  first month

• Percentage of patients without atrial fibrilation, flutter or tachycardia

  fourth month

• Percentage of patients without atrial fibrilation, flutter or tachycardia

  thirteen month

• Percentage of patient with cardioversion

  first month

• Percentage of patient with cardioversion

  fourth month

Study Arms (2)

Cryoablation

EXPERIMENTAL

Cryoablation for bidirectional block of all pulmonary veins

Device: Arctic Front Advance® balloon catheter; Device: Confirm RX heart monitor® (Abbott)

Antiarrythmics

ACTIVE COMPARATOR

The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.

Drug: Antiarrhythmic drug; Device: Confirm RX heart monitor® (Abbott)

Interventions

Arctic Front Advance® balloon catheter DEVICE

Cryoablation of bidirectional block of all pulmonary veins

Cryoablation

Antiarrhythmic drug DRUG

The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.

Also known as: Class I or III

Antiarrythmics

Confirm RX heart monitor® (Abbott) DEVICE

Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function

Antiarrythmics; Cryoablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent persistent atrial fibrilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 23, 2018
• Study Start: June 27, 2018
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)