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Pulmonary Vein Isolation (PVI) for Atrial Fibrillation ((SMILE-AF) Trial)

N/A

Waitlist Available

Led By Jorge E Romero, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

(SMILE-AF) Trial Summary

This trial will compare two different treatment approaches for patients with paroxysmal atrial fibrillation. One approach involves isolating the pulmonary veins, while the other involves isolating the left atrial posterior

Who is the study for?

This trial is for patients with paroxysmal atrial fibrillation, a type of irregular heartbeat. Specific eligibility criteria are not provided, but typically participants would need to be diagnosed with the condition and meet certain health standards.Check my eligibility

What is being tested?

The study compares two heart procedures: one where only the pulmonary veins are isolated (PVI), and another where PVI is combined with isolation of the left atrial posterior wall using pulsed-field ablation (PFA).See study design

What are the potential side effects?

While specific side effects aren't listed, procedures like these may cause chest discomfort, bleeding or bruising at puncture sites, heart rhythm problems, or more rarely stroke or heart damage.

(SMILE-AF) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.

The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.

Secondary outcome measures

Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).

Complications.

Freedom from atrial arrhythmias medication

+6 more

(SMILE-AF) Trial Design

2Treatment groups

Active Control

Group I: Pulmonary Vein Isolation (PVI)Active Control1 Intervention

Pulsed field ablation isolation of the pulmonary veins only.

Group II: Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)Active Control1 Intervention

Pulsed field ablation isolation of the pulmonary veins and the posterior wall of the left atrium.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,498 Total Patients Enrolled

35 Trials studying Atrial Fibrillation

2,052,156 Patients Enrolled for Atrial Fibrillation

Boston Scientific CorporationIndustry Sponsor

720 Previous Clinical Trials

932,572 Total Patients Enrolled

70 Trials studying Atrial Fibrillation

28,060 Patients Enrolled for Atrial Fibrillation

Jorge E Romero, MDPrincipal InvestigatorMass General Brigham

1 Previous Clinical Trials

124 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

124 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 20 years eligible to participate in this medical study?

"To be considered for participation in this research, individuals must be between 21 and 90 years old."

Answered by AI

Which specific criteria determine eligibility for participation in this experimental study?

"Patients aged between 21 and 90 years old with a confirmed diagnosis of atrial fibrillation are eligible to enroll in this research. The study aims to recruit 450 individuals who meet these criteria."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"As per the sponsor, Boston Scientific Corporation, the key focus of this study will be on Procedural success within a 12-month timeframe. This is defined as maintaining freedom from any recorded instances of atrial arrhythmias post a 3-month blanking period. Secondary outcomes to be evaluated include Procedure-related Recurrencies - described as the rate at which pulmonary vein and posterior wall reconnection occurs in patients necessitating repeat ablation procedures due to AF recurrence; fluoroscopy time assessment between groups; and Freedom from atrial arrhythmia medication usage comparison in terms of time and dosage between different cohorts."

Answered by AI

Are there still available openings for new participants in this research study?

"As per clinicaltrials.gov, patient recruitment is currently closed for this particular trial. The trial was first listed on June 1st, 2024 and last revised on April 11th, 2024. While enrollment is paused for this study, there are currently 485 other trials actively seeking participants."

Answered by AI

Recent research and studies

CirculationJournal

Worldwide Epidemiology of Atrial Fibrillation

Chugh, Sumeet S., Rasmus Havmoeller, Kumar Narayanan, David Singh, Michiel Rienstra, Emelia J. Benjamin, Richard F. Gillum, et al.. 2014. “Worldwide Epidemiology of Atrial Fibrillation”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.005119.

New England Journal of MedicineJournal

Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation

Andrade, Jason G., George A. Wells, Marc W. Deyell, Matthew Bennett, Vidal Essebag, Jean Champagne, Jean-Francois Roux, et al.. 2021. “Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2029980.

Journal of the American College of CardiologyJournal

Treatment of Atrial Fibrillation by the Ablation of Localized Sources

Narayan, Sanjiv M., David E. Krummen, Kalyanam Shivkumar, Paul Clopton, Wouter-Jan Rappel, and John M. Miller. 2012. “Treatment of Atrial Fibrillation by the Ablation of Localized Sources”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2012.05.022.

New England Journal of MedicineJournal