Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

Overview

The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.

Detailed description

This clinical investigation is intended to evaluate the safety and feasibility of Abbott's Volt™ Pulsed Field Ablation (PFA) System (Volt PFA System) and Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients with non-valvular atrial fibrillation who are indicated for both atrial fibrillation (AF) ablation and LAA occlusion (LAAO)

Interventions

• Procedure PVI Ablation
  PVI Ablation with Pulsed Field Ablation
• Device Left Atrial Appendage Occluder Implant
  Left atrial appendage occluder implant

Primary outcome measures

• LAA occlusion success determined by peri-device flow ≤5mm [Time frame: From treatment through 3-month follow-up vists]
• Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later [Time frame: From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later]

Eligibility criteria

Inclusion criteria

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• 18 years of age or older, or the age of legal consent
• CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
• Able to stop anticoagulation by 90 days post index procedure
• Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT
• Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF
• Documented symptomatic PAF or PersAF. Documentation requirements are as follows:

Paroxysmal:

• Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND
• One electrocardiographically documented PAF episode within 12 months prior to enrollment.

Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by

• Physician's note, AND either
• 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR
• Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:

• That are taken at least 7 days apart but less than 12 months apart
• If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
• The most recent electrocardiogram must be within 180 days of enrollment.

NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.

Exclusion criteria

• Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
• Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
• Patients with heart prosthetic valves
• Patient implanted with an inferior vena cava filter
• Patients with left ventricular ejection fraction ≤30%
• Patients with NYHA Class IV heart failure
• Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)
• Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure
• Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)
• Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
• Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure
• Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation
• Patients with a stent, constriction, or stenosis in a pulmonary vein
• Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
• Patients with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
• Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 3 centers

• Cardioangiologisches Centrum am Bethanien Krankenhaus — Frankfurt am Main
• Universitätsklinikum Schleswig-Holstein - Campus Lübeck — Lübeck
• Deutsches Herzzentrum der Charite — Berlin

Italy · 2 centers

• Centro Cardiologico Monzino — Milan
• ASST Grande Ospedale Metropolitano — Milan

Poland · 2 centers

• Slaskie Centrum Chorob Serca — Zabrze
• Centralny Szpital Kliniczny Uniwersytetu — Lodz

Spain · 2 centers

• Hospital de la Santa Creu I Sant Pau — Barcelona
• Clinica Universidad de Navarra — Pamplona

United Kingdom · 2 centers

• Royal Sussex County Hospital — Brighton
• John Radcliffe Hospital — Oxford

Belgium · 1 center

• UZ Brussel — Brussels

Czechia · 1 center

• Motol and Homolka University Hospital — Prague

Denmark · 1 center

• Rigshospitalet — Copenhagen

Ireland · 1 center

• Mater Private Hospital — Dublin

Lithuania · 1 center

• Vilnius University Hospital Santaros Klinikos — Vilnius

Identifiers

NCT: NCT07523620 · ABT-CIP-10617

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗