Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

NCT07523620 | Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10617
• Study Type: interventional
• Target: 240
• Locations: 9 countries
• Sites: 13

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Paroxysmal AF; Persistent Atrial Fibrillation

Keywords

Left Atrial Appendage; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• LAA occlusion success determined by peri-device flow ≤5mm

  The primary effectiveness outcome is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 3-month follow-up visit as assessed by an independent core laboratory

  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

  The primary safety outcome is defined as occurrence of one of the following between the time of implant and ≤7 days post-procedure or hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention * Includes pseudoaneurysm repair or AV fistula repair * Excludes percutaneous drainage of PE, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications

  From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later

Study Arms (1)

Treatment

EXPERIMENTAL

Concomitant procedure utilizing the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO implant.

Procedure: PVI Ablation; Device: Left Atrial Appendage Occluder Implant

Interventions

PVI Ablation PROCEDURE

PVI Ablation with Pulsed Field Ablation

Treatment

Left Atrial Appendage Occluder Implant DEVICE

Left atrial appendage occluder implant

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent prior to any clinical investigation-related procedure.
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

UZ Brussel

Brussels, B CAP R, 1090, Belgium

NOT YET RECRUITING

Motol and Homolka University Hospital

Prague, Czech Republic, 1500, Czechia

RECRUITING

Rigshospitalet

Copenhagen, Copenha, 2100, Denmark

NOT YET RECRUITING

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt am Main, Hesse, 60389, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schlesw, 23538, Germany

NOT YET RECRUITING

Deutsches Herzzentrum der Charite

Berlin, State of Berlin, 13353, Germany

NOT YET RECRUITING

Mater Private Hospital

Dublin, Dublin, Dublin 7, Ireland

NOT YET RECRUITING

Centro Cardiologico Monzino

Milan, Italy, 20138, Italy

RECRUITING

ASST Grande Ospedale Metropolitano

Milan, Lombard, 20162, Italy

NOT YET RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, Dzukija, 08406, Lithuania

NOT YET RECRUITING

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, 41-800, Poland

NOT YET RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalon, 08025, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Abeer Madbouly, Ph. D

CONTACT

651-497-5099; abeer.madbouly@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-01

Locations

BE (1); IE (1); LI (1); PL (1); ES (2); CZ (1); DE (3); IT (2); DK (1)