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

Cryoballoon Ablation for Early Persistent Atrial Fibrillation

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Holter monitoring

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France
    • Hôpital Henri Mondor
  • Grenoble, France
    • CHU de GRENOBLE
  • Marseille Cedex, France
    • CHU de la Timone
  • Rouen Cedex, France
    • CHU - Hôpitaux de Rouen
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW
  • Berlin, Germany, 10117
    • Charité - Universitaetsmedizin
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Hamburg, Germany
    • Asklepios Klinik St. Georg
  • Köln, Germany
    • Krankenhaus Porz am Rhein
  • Köln, Germany
    • St. Vinzenz-Hospital
  • Nürnberg, Germany
    • Klinikum Nürnberg Süd
  • Ulm, Germany
    • Uniklinik Ulm
• Greece
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cryoballoon ablation; Subjects will wear holter monitors at baseline, 6 months and 12 months	Other: Holter monitoring; Subjects will wear holter monitors at baseline, 6 months and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success of cryoballoon ablation on patients with early persistent AF	Acute procedural success is defined as: Only Arctic Front Advance catheters used to achieve procedure success AND; All targeted pulmonary veins were isolated (minimally assessed for entrance block and, where assessable, exit block) AND; Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)	Post-procedure
Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)	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 multiple 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. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.	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
Adverse events required to be collected during the study		12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2014
• Primary Completion (Actual): June 22, 2017
• Study Completion (Actual): September 12, 2017

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cryoablation; Persistent Atrial Fibrillation; Pulmonary Vein Isolation; Cryoballoon
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Cryo4 Persistent AF