Clinical trial NCT02213731: Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
Official title: Cryoballoon Ablation for Early Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Persistent Atrial Fibrillation
Cryoablation
Cryoballoon
Pulmonary Vein Isolation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2014-08-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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
* 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)

Primary outcomes:
measure: Single procedure success of cryoballoon ablation on patients with early persistent AF
timeFrame: 12 months
Secondary outcomes:
measure: Acute procedural success of cryoballoon ablation on patients with early persistent AF
timeFrame: Post-procedure
measure: Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)
timeFrame: 12 months
measure: Sinus rhythm restoration being followed by chronic prevention of AF recurrence
timeFrame: 12 months
measure: Use of class I and class III antiarrhythmic drugs
timeFrame: 12 months
measure: Changes in quality of life measurements between baseline, 6 months and 12 months after procedure
timeFrame: Baseline, 6 months, 12 months
measure: Adverse events required to be collected during the study
timeFrame: 12 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille Cedex
country: France
facility: CHU de la Timone
city: Rouen Cedex
country: France
facility: CHU - Hôpitaux de Rouen
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Köln
country: Germany
facility: Krankenhaus Porz am Rhein
city: Köln
country: Germany
facility: St. Vinzenz-Hospital
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Ulm
country: Germany
facility: Uniklinik Ulm
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
Study officials:
affiliation: Clinique Pasteur
name: Serge Boveda, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Michallo, Unité de Rythmologie, Clinique de cardiologie, CHU de Grenoble site Nord - Hôpital Albert Michallon
name: Pascal Defaye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: