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

NCT02213731 | Completed

• 1 other identifier: Cryo4 Persistent AF
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 14

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

Keywords

Atrial Fibrillation; Persistent Atrial Fibrillation; Cryoablation; Cryoballoon; Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Single procedure success of cryoballoon ablation on patients with early persistent AF

  12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias \>/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.

  12 months

Secondary Outcomes (6)

• Acute procedural success of cryoballoon ablation on patients with early persistent AF

  Post-procedure

• Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)

  12 months

• Sinus rhythm restoration being followed by chronic prevention of AF recurrence

  12 months

• Use of class I and class III antiarrhythmic drugs

  12 months

• Changes in quality of life measurements between baseline, 6 months and 12 months after procedure

  Baseline, 6 months, 12 months

Study Arms (1)

Cryoballoon ablation

OTHER

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

Other: Holter monitoring

Interventions

Holter monitoring OTHER

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

Cryoballoon ablation

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (14)

Hôpital Henri Mondor

Créteil, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de la Timone

Marseille, France

Location

CHU - Hôpitaux de Rouen

Rouen, France

Location

Clinique Pasteur

Toulouse, France

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Charite - Universitaetsmedizin

Berlin, 10117, Germany

Location

Krankenhaus Porz am Rhein

Cologne, Germany

Location

St. Vinzenz-Hospital

Cologne, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

Uniklinik Ulm

Ulm, Germany

Location

Henry Dunant Hospital Center

Athens, 11526, Greece

Location

Related Publications (1)

• 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.

  PMID: 30466850 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Serge Boveda, M.D.

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

• Pascal Defaye, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 11, 2014
• Study Start: December 8, 2014
• Primary Completion: June 22, 2017
• Study Completion: September 12, 2017
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DE (8); GR (1); FR (5)