NCT05560204

Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet

Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet: A Randomized Controlled Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation. Oral anticoagulant (OAC) therapy is currently the standard therapy before and after successful ablation. Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC. As both AF ablation and percutaneous LAAO require transseptal access from to left atrium, combining the two procedures into one single procedure may provide a straightforward strategy aiming at concomitant rhythm control as well as stroke prevention, without the additional risk of multiple procedures. It is showed in previous studies that this approach is feasible and safe. Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation. Irreversible electroporation is the application of high electric field to a cell with a resultant increased permeability of the membrane and downstream cell death. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. Therefore, with PFA the transseptal access for successful AF ablation is less demanding. Moreover, PFA would induce less pulmonary ridge edema compared to conventional ablation techniques and could potentially causes less PDL. Watchman Flx (Boston Scientific) and Amulet (Abbott) are the two most commonly used LAAO devices. The two devices have different designs, deployment requirements and occlusion results. Both devices have been used in combined procedure. However, there is no data of combined AF ablation and LAAO using the PFA technique, and of combined AF ablation comparing the use of Watchman Flx versus Amulet device. In this randomized controlled study, we aim to assess the feasibility and compare the peri-procedural outcomes and LAA occlusion result of combined AF ablation (using the PFA technique), and LAAO using either the Watchman Flx or the Amulet device.

Detailed description

Atrial fibrillation (AF) is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation. Oral anticoagulant (OAC) therapy is currently the standard therapy before and after successful ablation. Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC . As both AF ablation and percutaneous LAAO require transseptal access from to left atrium, combining the two procedures into one single procedure may provide a straightforward strategy aiming at concomitant rhythm control as well as stroke prevention, without the additional risk of multiple procedures. It is showed in previous studies that this approach is feasible and safe. However, the current AF ablation techniques (radiofrequency ablation and cryoballoon ablation) requires a less posterior transseptal access while LAAO requires a posterior-inferior transseptal access. This could potentially make LAAO after same procedure AF ablation using the same transseptal access more challenging. Besides, current ablation techniques would induce edema over pulmonary ridge, which could potentially result in significant peri-device leak (PDL) post LAAO after edema subsided. Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation. Irreversible electroporation is the application of high electric field to a cell with a resultant increased permeability of the membrane and downstream cell death. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. Therefore, with PFA the transseptal access for successful AF ablation is less demanding. Moreover, PFA would induce less pulmonary ridge edema compared to conventional ablation techniques and could potentially causes less PDL. Watchman Flx (Boston Scientific) and Amulet (Abbott) are the two most commonly used LAAO devices. The two devices have different designs, deployment requirements and occlusion results. Both devices have been used in combined procedure. However, there is no data of combined AF ablation and LAAO using the PFA technique, and of combined AF ablation comparing the use of Watchman Flx versus Amulet device. In this randomized controlled study, we aim to assess the feasibility and compare the peri-procedural outcomes and LAA occlusion result of combined AF ablation (using the PFA technique), and LAAO using either the Watchman Flx or the Amulet device.

Conditions

• Combined Pulsed-field Ablation (PFA)

Interventions

Type	Name	Description
DEVICE	Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)	Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-09-29
• Last updated: 2024-11-29

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study