NCT03716934

CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-27
• Primary completion: 2022-04-18
• Completion: 2022-04-18
• First posted: 2018-10-23
• Last updated: 2025-09-15

Locations

1 site across 1 country: Spain