Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

NCT ID: NCT02213731

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-08
• Study Completion Date: 2017-09-12

Brief Summary

The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoballoon ablation

Subjects will wear holter monitors at baseline, 6 months and 12 months

Group Type: OTHER

Holter monitoring

Intervention Type: OTHER

Subjects will wear holter monitors at baseline, 6 months and 12 months.

Interventions

Holter monitoring

Subjects will wear holter monitors at baseline, 6 months and 12 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:

• Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
• Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
• Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
• Age between 18 and 75 years
• Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study

Exclusion Criteria

• Long-standing persistent AF (has lasted for ≥1 year)
• Current diagnosis of paroxysmal AF
• Anteroposterior LA diameter > 5.0 cm by TTE
• Current intracardiac thrombus
• Presence of one or more pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Primary pulmonary hypertension
• NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE)
• Hypertrophic cardiomyopathy
• Previous LA ablation or surgery
• Unstable angina
• Presence of any cardiac valve prosthesis
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
• Cryoglobulinemia
• Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
• Uncontrolled hyperthyroidism
• Any woman known to be pregnant or breastfeeding
• Active systemic infection
• Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
• Life expectancy ≤ 1 year
• Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serge Boveda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur

Pascal Defaye, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon

Locations

Hôpital Henri Mondor

Créteil, , France

CHU de Grenoble

Grenoble, , France

CHU de la Timone

Marseille, , France

CHU - Hôpitaux de Rouen

Rouen, , France

Clinique Pasteur

Toulouse, , France

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Charite - Universitaetsmedizin

Berlin, , Germany

Krankenhaus Porz am Rhein

Cologne, , Germany

St. Vinzenz-Hospital

Cologne, , Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Uniklinik Ulm

Ulm, , Germany

Henry Dunant Hospital Center

Athens, , Greece

Countries

France; Germany; Greece

References

Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K, Noelker G, Deharo JC, Andrikopoulos G, Dahme T, Lellouche N, Defaye P. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol. 2018 Nov;4(11):1440-1447. doi: 10.1016/j.jacep.2018.07.007. Epub 2018 Aug 25.

Reference Type: DERIVED

PMID: 30466850 (View on PubMed)

Other Identifiers

Cryo4 Persistent AF

Identifier Type: -

Identifier Source: org_study_id