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

November 26, 2024 updated by: Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Shatin
      • Hong Kong, Shatin, Hong Kong, 0000
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

This is based on the primary objective, previous data in Hong Kong and calculation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Watchman Flx
Watchman Flx device to be used for LAAO
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
Active Comparator: Amulet
Amulet device to be used for LAAO
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LAAO technical success rate
Time Frame: Baseline
successful device implantation without device related complication and peri-device leak >5mm
Baseline
Rate of procedural related complications
Time Frame: baseline, 45-90 days, 6-months, 12-months
stroke, pericardial effusion, device embolization, mortality
baseline, 45-90 days, 6-months, 12-months
PFA acute technical success
Time Frame: baseline, 45-90 days, 6-months, 12-months
electric isolation of 4 pulmonary veins) by pre-ablation and post ablation mapping
baseline, 45-90 days, 6-months, 12-months
AF ablation procedural success
Time Frame: baseline, 45-90 days, 6-months, 12-months
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
baseline, 45-90 days, 6-months, 12-months
Number of Participants with 1-year clinical events
Time Frame: baseline, 45-90 days, 6-months, 12-months
bleeding or thromboembolic event
baseline, 45-90 days, 6-months, 12-months
Total ablation time
Time Frame: baseline, 45-90 days, 6-months, 12-months
Total ablation time
baseline, 45-90 days, 6-months, 12-months
LAAO procedural time
Time Frame: baseline, 45-90 days, 6-months, 12-months
LAAO procedural time
baseline, 45-90 days, 6-months, 12-months
Need of additional transseptal puncture for LAAO
Time Frame: baseline, 45-90 days, 6-months, 12-months
Need of additional transseptal puncture for LAAO
baseline, 45-90 days, 6-months, 12-months
Number of device recapture (full or partial)
Time Frame: baseline, 45-90 days, 6-months, 12-months
Number of device recapture (full or partial)
baseline, 45-90 days, 6-months, 12-months
Number of device used
Time Frame: baseline, 45-90 days, 6-months, 12-months
Number of device used
baseline, 45-90 days, 6-months, 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Investigators

  • Principal Investigator: Chak YU So, MBChB, Prince of Wales Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022.494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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