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

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Radiofrequency Ablation
• Intervention / Treatment: Procedure: Radiofrequency ablation

• Study Type: Observational
• Enrollment (Anticipated): 127

Contacts and Locations

• Study Contact: Name: Ahmad A.A. Farghaly, MD; Phone Number: +2 01007174534; Email: ahmadabdelrady20@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We enroll all symptomatic AF patients who referred to first (de- novo) RF ablation within (early) vs. after (late) one year from the first AF diagnosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early referral to ablation within one year after first documented AF diagnosis	Procedure: Radiofrequency ablation; pulmonary vein isolation using radiofrequency ablation.
Delayed referral to ablation after one year after first documented AF diagnosis	Procedure: Radiofrequency ablation; pulmonary vein isolation using radiofrequency ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from any atrial arrhythmia after single ablation procedure.	freedom from any documented atrial arrhythmia lasted for more than 30 seconds.	12 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Kuck KH, Lebedev DS, Mikhaylov EN, Romanov A, Geller L, Kalejs O, Neumann T, Davtyan K, On YK, Popov S, Bongiorni MG, Schluter 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 6, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): October 30, 2023

Study Registration Dates

• First Submitted: September 24, 2022
• First Submitted That Met QC Criteria: September 24, 2022
• First Posted (ACTUAL): September 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Early referral, catheter ablation, atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Early Referral to AF Ablation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No