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NCT05559073 | Not yet recruiting | Atrial Fibrillation


Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.
Sponsor:

Assiut University

Information provided by (Responsible Party):

Ahmed Abdel Radi Abdel Salam Farghaly

Brief Summary:

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality. The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation. In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone. Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments. The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs. Patients >_65 years were significantly more likely to progress to persistent AF/AT than patients were <65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression. So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.

Condition or disease

Atrial Fibrillation

Radiofrequency Ablation

Intervention/treatment

Radiofrequency ablation

Study Type : Observational
Estimated Enrollment : 127 participants
Official Title : Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation
Actual Study Start Date : October 6, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : October 30, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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 >30 seconds 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 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 transthoracic echocardiography
  • Cardiac valve prosthesis
  • Severe mitral valve regurgitation or stenosis
  • Myocardial infarction, percutaneous intervention, or coronary artery stenting during the 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-month interval preceding the consent date
  • Pregnancy and Life expectancy less than one year

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.

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Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.

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