Clinical trial NCT05560204: Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
Official title: Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Combined Pulsed-field Ablation (PFA)
Keywords: Combined Pulsed-field Ablation (PFA)
Left Atrial Appendage Occlusion (LAAO)
Atrial fibrillation (AF)
Oral anticoagulant (OAC)
non-valvular atrial fibrillation (NVAF)
Transesophageal echocardiog
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Paroxysmal or persistent non- valvular atrial fibrillation
2. CHADS2-VASc \>=2
3. Age \>=18; and able to give written consent

Exclusion Criteria:

1. are in permanent atrial fibrillation
2. are not eligible for 3 months of oral anticoagulant post ablation
3. has left Atrial thrombus identified by pre-procedure TEE or during procedure
4. had received prior left atrial appendage closure procedure (percutaneous or surgical)
5. are planned to receive concomitant ablation procedure or structural heart interventions other than AF ablation and LAAO (e.g SVT ablation, Aflutter ablation, PFO closure, leadless pacemaker, ASD Closure, etc)
6. patient whom refused or cannot tolerate procedural or post procedural follow-up TEE

Primary outcomes:
measure: Rate of >=moderate peri-device leak (i.e. >=3mm) on follow-up TEE
timeFrame: 45-90 days
Secondary outcomes:
measure: LAAO technical success rate
timeFrame: Baseline
measure: Rate of procedural related complications
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: Total ablation time
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: LAAO procedural time
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: Need of additional transseptal puncture for LAAO
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: Number of device recapture (full or partial)
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: Number of device used
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: PFA acute technical success
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: AF ablation procedural success
timeFrame: baseline, 45-90 days, 6-months, 12-months
measure: Number of Participants with 1-year clinical events
timeFrame: baseline, 45-90 days, 6-months, 12-months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Prince of Wales Hospital
name: Chak YU So, MBChB
role: PRINCIPAL_INVESTIGATOR
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