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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05559073
• Collaborator: (none)
• Enrollment: 127
• Anticipated Duration (Months): 12.8

Study Details

Study Description

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	Intervention/Treatment	Phase
Atrial Fibrillation; Radiofrequency Ablation	Procedure: Radiofrequency ablation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 127 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation
• Anticipated Study Start Date: Oct 6, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Freedom from any atrial arrhythmia after single ablation procedure. [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ahmad Abdelrady Abdelsalam Farghaly, Assistant lecturer of cardiovascular medicine, Assiut University
• ClinicalTrials.gov Identifier: NCT05559073
• Other Study ID Numbers: Early Referral to AF Ablation
• First Posted: Sep 29, 2022
• Last Update Posted: Sep 29, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmad Abdelrady Abdelsalam Farghaly, Assistant lecturer of cardiovascular medicine, Assiut University: Early referral, catheter ablation, atrial fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 29, 2022