Actively Recruiting
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Led by Abbott Medical Devices · Updated on 2026-05-27
240
Participants Needed
13
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of combining two procedures—the Volt Pulsed Field Ablation (PFA) System and the Amulet 2 Left Atrial Appendage occluder device—in patients with non-valvular atrial fibrillation who need both atrial fibrillation ablation and left atrial appendage occlusion. This investigation aims to assess how well these devices work together during a concomitant procedure for rhythm restoration and stroke risk reduction. The study involves performing catheter ablation for pulmonary vein isolation using the Volt PFA System along with implanting the Amulet 2 occluder device in a single procedure. Patients undergo this combined treatment and are then monitored for success of the occlusion and any adverse events occurring from the time of implant through a 3-month follow-up. The study does not include a comparison group and focuses on a single treatment arm. Participants will be involved from the time of the combined procedure through follow-up visits up to 3 months after treatment. Researchers will evaluate the success of left atrial appendage occlusion based on peri-device blood flow and monitor for specific adverse events up to 7 days post-procedure or until hospital discharge. The study includes assessments such as clinical evaluations and imaging to measure occlusion success and safety outcomes throughout the follow-up period.
CONDITIONS
Brief Title
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 paroxysmal or persistent atrial fibrillation
- Documented symptomatic paroxysmal atrial fibrillation with 2 episodes in the prior 12 months and electrocardiographic documentation within 12 months prior to enrollment
- Documented symptomatic persistent atrial fibrillation sustained beyond 7 days and less than 1 year with physician note and appropriate electrocardiographic evidence
You will not qualify if you...
- 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)
- Presence of heart prosthetic valves
- Implanted inferior vena cava filter
- Left ventricular ejection fraction 30%
- New York Heart Association Class IV heart failure
- Invasive intervention or surgery within 30 days prior to index procedure (excluding diagnostic catheterization)
- Stroke or transient ischemic attack within 90 days prior to study procedure
- Previous attempt at left atrial appendage surgical or epicardial intervention
- Long-standing persistent atrial fibrillation (continuous AF > 1 year)
- Arrhythmia due to reversible causes such as thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, or major surgery within 90 days
- Unable to receive heparin or acceptable alternative for anticoagulation during procedure
- Stent, constriction, or stenosis in a pulmonary vein
- Severe mitral regurgitation (specific volumetric and area thresholds)
- Severe renal failure (eGFR < 30 ml/min/1.73m2) or chronic dialysis
- Severe pulmonary disease causing chronic symptoms
- Hypertrophic cardiomyopathy with maximal left ventricular wall thickness 15 mm without abnormal loading conditions such as hypertension or aortic stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with post-procedure monitoring up to 7 days or hospital discharge, whichever is later
Participants undergo a concomitant procedure including pulmonary vein isolation ablation using the Volt Pulsed Field Ablation System and implantation of the Amulet 2 left atrial appendage occluder device.
1 procedure visit and daily monitoring visits up to 7 days or hospital discharge
Duration - Up to 3 months post-procedure
Participants are followed for safety and efficacy assessments including evaluation of left atrial appendage occlusion success and adverse events.
Multiple follow-up visits up to 3 months
Trial Site Locations
Total: 13 locations
1
UZ Brussel
Brussels, B CAP R, Belgium, 1090
Not Yet Recruiting
2
Motol and Homolka University Hospital
Prague, Czech Republic, Czechia, 1500
Actively Recruiting
3
Rigshospitalet
Copenhagen, Copenha, Denmark, 2100
Not Yet Recruiting
4
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany, 60389
Not Yet Recruiting
5
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schlesw, Germany, 23538
Not Yet Recruiting
6
Deutsches Herzzentrum der Charite
Berlin, State of Berlin, Germany, 13353
Not Yet Recruiting
7
Mater Private Hospital
Dublin, Dublin, Ireland, Dublin 7
Not Yet Recruiting
8
Centro Cardiologico Monzino
Milan, Italy, Italy, 20138
Actively Recruiting
9
ASST Grande Ospedale Metropolitano
Milan, Lombard, Italy, 20162
Not Yet Recruiting
10
Vilnius University Hospital Santaros Klinikos
Vilnius, Dzukija, Lithuania, 08406
Not Yet Recruiting
11
Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, Poland, 41-800
Not Yet Recruiting
12
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalon, Spain, 08025
Not Yet Recruiting
13
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Not Yet Recruiting
Research Team
A
Abeer Madbouly, Ph. D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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