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

Medtronic Cardiac Ablation Solutions

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Holter monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT02213731

Cryo4 Persistent AF

Details and patient eligibility

About

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).

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Cryoballoon ablation

Other group

Description:

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

Treatment:

Other: Holter monitoring