Status:
COMPLETED
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02213731
Start Date
December 8 2014
End Date
September 12 2017
Last Update
February 13 2025
Active Locations (14)
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1
Hôpital Henri Mondor
Créteil, France
2
CHU de Grenoble
Grenoble, France
3
CHU de la Timone
Marseille, France
4
CHU - Hôpitaux de Rouen
Rouen, France