Last updated: September 24, 2022
Sponsor: Assiut University
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Arrhythmia
Cardiac Disease
Chest Pain
Treatment
N/AClinical Study ID
NCT05559073
Early Referral to AF Ablation
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG,trans-telephonic monitoring (TTM) or Holter monitor (episodes of AF must be >30seconds in duration to qualify as an inclusion criterion)
- Age of 18 years or older on the date of consent.
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Exclusion
Exclusion Criteria: Permenant AF
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active intracardiac thrombus
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
- Contraindication to anticoagulation or radiocontrast materials
- Left atrial anteroposterior diameter greater than 5.5 cm by transthoracicechocardiography
- Cardiac valve prosthesis
- Severe mitral valve regurgitation or stenosis
- Myocardial infarction, percutaneous intervention, or coronary artery stenting duringthe 3-month period preceding the consent date
- Cardiac surgery during the three-month interval preceding the consent date
- Significant unrepaird congenital heart defect (including patent foramen ovale)
- NYHA class IV congestive heart failure
- Significant chronic kidney disease (eGFR <30 mL/min/1.73m2)
- Cerebral ischemic event (stroke or transient ischemic attack) during the six-monthinterval preceding the consent date
- Pregnancy and Life expectancy less than one year
Study Design
Total Participants: 127
Study Start date:
October 06, 2022
Estimated Completion Date:
October 30, 2023