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

Atrial Fibrillation Clinical Trial

Official title:

Cryoballoon Ablation for Early Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213731
• Other study ID #: Cryo4 Persistent AF
• Status: Completed
• Phase: N/A
• Start date: December 8, 2014
• Est. completion date: September 12, 2017

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 12, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Holter monitoring
Subjects will wear holter monitors at baseline, 6 months and 12 months.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

France,  Germany,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Sinus rhythm restoration being followed by chronic prevention of AF recurrence		12 months
Secondary	Use of class I and class III antiarrhythmic drugs		12 months
Secondary	Changes in quality of life measurements between baseline, 6 months and 12 months after procedure		Baseline, 6 months, 12 months
Secondary	Adverse events required to be collected during the study		12 months