Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Atrial Fibrillation Paroxysmal Clinical Trial

— (SMILE-AF)  

Official title:

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364215
• Other study ID #: 2024P000883
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Obadah Aloum, MD
• Phone: 6177325241
• Email: oaloum[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Age 21-90 years.

4. Symptomatic PAF whether failed AAD or not.

5. At least one symptomatic episode of PAF lasting <7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.

6. Patients undergoing first time ablation for AF.

Exclusion Criteria:

1. Persistent atrial fibrillation (PeAF) (> 7 days in duration).

2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.

3. Previous surgical or catheter ablation of AF.

4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.

5. left atrial anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA) volume >48 ml/m2.

6. Contraindications to oral or systemic anticoagulation.

7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.

8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.

9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).

10. Pregnancy.

11. History of PV stenosis.

12. History of severe pulmonary hypertension.

13. History of diaphragmatic paresis or hemi-paresis.

14. History of heart transplantation.

15. History of blood clotting or bleeding abnormalities.

16. Life expectancy of less than 12 months.

17. Presence of intracardiac thrombus.

18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.

19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.

20. Pacing dependent patients.

21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).

22. Active systemic infection.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal

Intervention

Procedure:
• Pulmonary Vein Isolation alone
Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
• Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.	will be assessed by: Occurrence of all atrial arrhythmias after the 3-month blanking period.; Any cardioversion for atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) after the 3-month blanking period.; Use of any type I or type III antiarrhythmic medication for the treatment of AF, AFL, or AT after the 3-month blanking period, or the use of amiodarone at any time.; Re-ablation of AF, AFL, or AT.	12 months
Primary	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.	All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration	12 Months
Secondary	Freedom from atrial arrhythmias medication	Time and dose of anti arrhythmic medications use will be compared between the two groups.	12 Months
Secondary	Procedural time	procedural time will be compared among groups.	12 Months
Secondary	Procedure-related Recurrencies	Rate of PV and PW reconnection in patients undergoing repeat ablation procedures for recurrence of AF.	12 Months
Secondary	Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).	It reports scores from 0 to 100. A score of 0 corresponds to complete disability, while a score of 100 describes the highest level of QoL	12 Months
Secondary	Use of amiodarone	Number of patients using amiodarone, and duration of using it will be compared among groups.	12 months
Secondary	Complications.	Incidence of acute procedure-related complications and long-term procedure-related complication.	12 Months.
Secondary	fluoroscopy time.	fluoroscopy time will be asses between the two groups.	during 1-2 hours procedure.
Secondary	Pulsed field ablation (PFA) applications during procedure.	The PFA count will be compared by the two groups.	During 1-2 hours procedure.
Secondary	first-pass pulmonary vein isolation (PVI).	the rates of first pass PVI will be compared between the two groups.	During 1-2 hours procedure.

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