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

Atrial Fibrillation Clinical Trial

Official title:

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05559073
• Other study ID #: Early Referral to AF Ablation
• Status: Not yet recruiting
• Start date: October 6, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: Ahmad A.A. Farghaly, MD
• Phone: 01007174534
• Email: ahmadabdelrady20[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 127
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Radiofrequency Ablation

Intervention

Procedure:
• Radiofrequency ablation
pulmonary vein isolation using radiofrequency ablation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Kuck KH, Lebedev DS, Mikhaylov EN, Romanov A, Gellér L, Kalejs O, Neumann T, Davtyan K, On YK, Popov S, Bongiorni MG, Schlüter M, Willems S, Ouyang F. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. 2021 Mar 8;23(3):362-369. doi: 10.1093/europace/euaa298. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from any atrial arrhythmia after single ablation procedure.	freedom from any documented atrial arrhythmia lasted for more than 30 seconds.	12 months