ClinicaliQ Trial Snapshot
- Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT07523620.
- What is being tested: This trial evaluates a combined procedure using the Volt PFA System for atrial fibrillation ablation alongside the Amulet 2 device for left atrial appendage occlusion in patients requiring both interventions.
- Patient eligibility overview: The trial targets patients with atrial fibrillation who have concurrent indications for both catheter ablation and percutaneous left atrial appendage closure, typically those with elevated stroke risk unable to tolerate long-term anticoagulation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.