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

NCT05559073 | Unknown

• 1 other identifier: Early Referral to AF Ablation
• Study Type: observational
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Radiofrequency Ablation

Keywords

Early referral, catheter ablation, atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from any atrial arrhythmia after single ablation procedure.

  freedom from any documented atrial arrhythmia lasted for more than 30 seconds.

  12 months

Study Arms (2)

Early referral to ablation within one year after first documented AF diagnosis

Procedure: Radiofrequency ablation

Delayed referral to ablation after one year after first documented AF diagnosis

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

pulmonary vein isolation using radiofrequency ablation.

Delayed referral to ablation after one year after first documented AF diagnosis; Early referral to ablation within one year after first documented AF diagnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age of 18 years or older on the date of consent.
• Candidate for ablation based on AF that is symptomatic
• Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 33330909 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Ahmad A.A. Farghaly, MD

CONTACT

01007174534; ahmadabdelrady20@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of cardiovascular medicine

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 29, 2022
• Study Start: October 6, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09