CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

NCT03716934 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2022-04-18
Completion
2022-04-18

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03716934 on ClinicalTrials.gov