CRioablation vs Antiarrhythmic Drugs for Persistent Atrial Fibrillation Trial (CRAFT)
- Conditions
- Recurrent Persistent Atrial FibrillationMedDRA version: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004202-18-ES
- Lead Sponsor
- Fundación Interhospitalaria para la Investigación Cardiovascular
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
Patients with recurrent persistent AF
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Patients with AF for more than one year at baseline
• FA prior ablation
• Age> 75 years or <18 years
• Hyperthyroidism
•Hypertrophic cardiomyopathy
• Severe valvular disease (stenosis or regurgitation)
• Carriers of cardiac valves
• AP Diameter of AI> 50 mm (left parasternal long axis)
• Contraindications for anticoagulation
• Left atrial thrombus
• Anemia
• Active infection
• Pregnancy
• FA secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)
• Life expectancy of less than 24 months
• Participation in another non-purely observational study
• Patients unable to understand treatment and / or study and / or providing adequate informed consent
• Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method