PVI Ablation: PVI Ablation with Pulsed Field Ablation
Left Atrial Appendage Occluder Implant: Left atrial appendage occluder implant
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
LAA occlusion success determined by peri-device flow ≤5mm — From treatment through 3-month follow-up vists 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
Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later — From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is 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
Trial sites (16)
Facility
City
Region
Status
UZ Brussel
Brussels
B CAP R
Recruiting
Motol and Homolka University Hospital
Prague
Czech Republic
Recruiting
Rigshospitalet
Copenhagen
Copenha
Recruiting
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main
Hesse
Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.