Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial

NCT06334250 | Withdrawn DMC

• 1 other identifier: IRAS:327077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation.

Conditions

Atrial Fibrillation

Keywords

Left atrial appendage occlusion; Catheter ablation; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in quality of lfie

  Change in quality of life from baseline to 12 months as measured by the Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) questionnaire

  Measured at baseline and at 12 months following the procedure

Secondary Outcomes (4)

• Time to atrial fibrillation recurrence

  From the day of the procedure to end of follow-up at 12 months

• Requirement for unplanned further ablation or cardioversion procedures

  From the day of the procedure to end of follow-up at 12 months

• Procedural metrics

  On the day of the left atrial appendage +/- pulsed field ablation procedure

• Procedural safety outcomes

  From the day of the procedure to end of follow-up at 12 months

Study Arms (2)

Left atrial appendage occlusion alone

ACTIVE COMPARATOR

Left atrial appendage occlusions with the Watchman device (Boston Scientific)

Device: Left atrial appendage occlusion

Combined left atrial appendage occlusion and pulsed field ablation of atrial fibrillation

EXPERIMENTAL

Left atrial appendage occlusion with the Watchman device (Boston Scientific) and catheter ablation of atrial fibrillation with the FaraPulse system (Boston Scientific)

Device: Catheter ablation of atrial fibrillation using Pulsed Field Ablation; Device: Left atrial appendage occlusion

Interventions

Catheter ablation of atrial fibrillation using Pulsed Field Ablation DEVICE

Pulsed Field Ablation of atrial fibrillation at the time of left atrial appendage occlusion

Also known as: FaraPulse (Boston Scientific), Electroporation

Combined left atrial appendage occlusion and pulsed field ablation of atrial fibrillation

Left atrial appendage occlusion DEVICE

Left atrial appendage occlusion using the Watchman device

Also known as: Watchman device

Combined left atrial appendage occlusion and pulsed field ablation of atrial fibrillation; Left atrial appendage occlusion alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal or Persistent AF, aged 18-80
• Presence of symptoms attributable to AF: EHRA 2 and above
• Clinical indication for LAAO procedure
• Own smartphone compatible with AliveCor device

You may not qualify if:

• Permanent AF
• Body mass index ≥40
• Previous LA ablation procedure
• Severely enlarged LA (\>50mm antero-posterior diameter)
• Severely impaired left ventricular function (ejection fraction \< 35%)
• Severe valvular disease
• Significant renal impairment (estimated glomerular filtration rate \< 30)
• Pregnancy
• Significant frailty (Clinical Frailty Score \< 5)
• Non-AF arrhythmia (e.g., atypical flutter, focal atrial tachycardia, other narrow complex tachycardias)
• Inability to provide informed consent

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electroporation; Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Cardiac Catheterization; Catheterization; Therapeutics

Study Officials

• Dhiraj Gupta, MD

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)