Status:
COMPLETED
Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablat...
Detailed Description
Atrial fibrillation (AF) is the most common heart rhythm disorder and carries considerable mortality, morbidity and socio-economic costs in western societies. Treatment options include anticoagulation...
Eligibility Criteria
Inclusion
- Paroxysmal atrial fibrillation
- \>2 episodes in 3 months prior to enrollment
- Clinical indication for ablation
Exclusion
- Contraindication for ablation
- Valvular heart disease
- Persistent AF only (\>7 days duration or \<7 days duration but requiring cardioversion, as persistent AF was customarily defined at the beginning of this study)
- Documented atrial flutter or other arrhythmias requiring other ablation than PVI
- Implanted pacemaker or defibrillator
- Pregnancy
- Malignant disease (non metastatic skin cancer excluded)
- Obesity (BMI \>35)
- Uncontrolled hypertension (BT \> 160/100 mmHg on repeated measurements)
- Severe sleep apnea
- Active systemic infection
- Renal insufficiency with S-creatinin \> 150 micromol/l
- Psychiatric illness or substance abuse
- Participation in other clinical studies involving medical treatment
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03805555
Start Date
June 1 2015
End Date
October 1 2020
Last Update
September 8 2021
Active Locations (1)
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1
Gentofte Hospital
Hellerup, Denmark, 2820