Combined Pulsed-field Ablation (PFA)COMPAWANCT05560204

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

A study testing Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO) in people with Combined Pulsed-field Ablation (PFA), run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Combined Pulsed-field Ablation (PFA)
What is being tested?: Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteHong Kong
Study dates: 1 Jan 2023to 31 Dec 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

are in permanent atrial fibrillation
are not eligible for 3 months of oral anticoagulant post ablation
has left Atrial thrombus identified by pre-procedure TEE or during procedure
had received prior left atrial appendage closure procedure (percutaneous or surgical)
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)
patient whom refused or cannot tolerate procedural or post procedural follow-up TEE

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Prince of Wales Hospital
Hong Kong, Shatin, 0000

Other trials in Hong Kong

About this study

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

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.

Read the 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)
Being tested: Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
Keywords: Combined Pulsed-field Ablation (PFA), Left Atrial Appendage Occlusion (LAAO), Atrial fibrillation (AF), Oral anticoagulant (OAC), non-valvular atrial fibrillation (NVAF), Transesophageal echocardiog
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)Device
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

Study groups in NCT05560204
Study group	Role	What they receive
Watchman Flx	Active comparator	Watchman Flx device to be used for LAAO Receives: Device: Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
Amulet	Active comparator	Amulet device to be used for LAAO Receives: Device: Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of >=moderate peri-device leak (i.e. >=3mm) on follow-up TEE
Rate of >=moderate peri-device leak (i.e. >=3mm) on follow-up TEE
Measured: 45-90 days

Secondary outcomes (10)

LAAO technical success rate
successful device implantation without device related complication and peri-device leak >5mm
Measured: Baseline
Rate of procedural related complications
stroke, pericardial effusion, device embolization, mortality
Measured: baseline, 45-90 days, 6-months, 12-months
Total ablation time
Total ablation time
Measured: baseline, 45-90 days, 6-months, 12-months
LAAO procedural time
LAAO procedural time
Measured: baseline, 45-90 days, 6-months, 12-months
Need of additional transseptal puncture for LAAO
Need of additional transseptal puncture for LAAO
Measured: baseline, 45-90 days, 6-months, 12-months
Number of device recapture (full or partial)
Number of device recapture (full or partial)
Measured: baseline, 45-90 days, 6-months, 12-months
Number of device used
Number of device used
Measured: baseline, 45-90 days, 6-months, 12-months
PFA acute technical success
electric isolation of 4 pulmonary veins) by pre-ablation and post ablation mapping
Measured: baseline, 45-90 days, 6-months, 12-months
AF ablation procedural success
AF ablation procedural success, defined as no ECG, holter, or rhythm strip documentation of recurrence of AF, AT, Aflutter lasting more than 30 seconds at 1 year
Measured: baseline, 45-90 days, 6-months, 12-months
Number of Participants with 1-year clinical events
bleeding or thromboembolic event
Measured: baseline, 45-90 days, 6-months, 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202331 Dec 2027

First posted29 Sep 2022
Study start1 Jan 2023
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Combined Pulsed-field Ablation (PFA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05560204
Sponsor's protocol ID: 2022.494
Acronym: COMPAWA
Status last verified: Sep 2026
First submitted: 26 Sep 2022
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505
January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available.
PubMed 30703431
Phillips KP, Walker DT, Humphries JA. Combined catheter ablation for atrial fibrillation and Watchman(R) left atrial appendage occlusion procedures: Five-year experience. J Arrhythm. 2016 Apr;32(2):119-26. doi: 10.1016/j.joa.2015.11.001. Epub 2015 Dec 8.
PubMed 27092193
Swaans MJ, Alipour A, Rensing BJ, Post MC, Boersma LV. Catheter ablation in combination with left atrial appendage closure for atrial fibrillation. J Vis Exp. 2013 Feb 26;(72):e3818. doi: 10.3791/3818.
PubMed 23486416
Alipour A, Swaans MJ, van Dijk VF, Balt JC, Post MC, Bosschaert MAR, Rensing BJ, Reddy VY, Boersma LVA. Ablation for Atrial Fibrillation Combined With Left Atrial Appendage Closure. JACC Clin Electrophysiol. 2015 Dec;1(6):486-495. doi: 10.1016/j.jacep.2015.07.009. Epub 2015 Oct 22.
PubMed 29759402
Calvo N, Salterain N, Arguedas H, Macias A, Esteban A, Garcia de Yebenes M, Gavira JJ, Barba J, Garcia-Bolao I. Combined catheter ablation and left atrial appendage closure as a hybrid procedure for the treatment of atrial fibrillation. Europace. 2015 Oct;17(10):1533-40. doi: 10.1093/europace/euv070. Epub 2015 May 1.
PubMed 25935163
Fassini G, Conti S, Moltrasio M, Maltagliati A, Tundo F, Riva S, Dello Russo A, Casella M, Majocchi B, Zucchetti M, Russo E, Marino V, Pepi M, Tondo C. Concomitant cryoballoon ablation and percutaneous closure of left atrial appendage in patients with atrial fibrillation. Europace. 2016 Nov;18(11):1705-1710. doi: 10.1093/europace/euw007. Epub 2016 Jul 11.
PubMed 27402623
Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.
PubMed 29106523
He B, Jiang LS, Hao ZY, Wang H, Miao YT. Combination of ablation and left atrial appendage closure as "One-stop" procedure in the treatment of atrial fibrillation: Current status and future perspective. Pacing Clin Electrophysiol. 2021 Jul;44(7):1259-1266. doi: 10.1111/pace.14201. Epub 2021 Mar 9.
PubMed 33629763
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
PubMed 33933412
Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
PubMed 31085321
Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O'Brien L, Windecker S. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021 Nov 9;144(19):1543-1552. doi: 10.1161/CIRCULATIONAHA.121.057063. Epub 2021 Aug 30.
PubMed 34459659
Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.
PubMed 27540038