Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study

A vizsgálat adatai

Ki végzi

AtaCor Medical, Inc.

Azonosító

NCT07324031

A regiszteradat frissítve

2026. október 9.

Eredeti leírás

The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System.A teljes eredeti leírásKevesebb

The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System.

The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.

Bevonási feltételek: At least 18 years old; Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines.

Kizáró feltételek: Participation in any concurrent clinical study without prior approval from the Sponsor; Implanted with or planned implantation of any device which delivers current in the body that may interfere with therapy delivery, including, but not limited to a pacemaker, LVAD or neurostimulator; Any known need for MRI prior to approval of MRI conditional labeling; Anatomy Related:; Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type; Currently on inotropic therapy; Allergies to any device materials listed in the Instructions for Use (IFU); Known history of lung disease with FEV1 < 1.0 Liter; Device Related:; Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure; History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure; Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax; Surgically corrected congenital heart disease (not including catheter-based procedures); Cardiac Related:; Indication for permanent bradycardia pacing or cardiac resynchronization therapy; Decompensated heart failure; Known history of pericardial disease, pericarditis or mediastinitis; Risk factors associated with defibrillation testing:; Severe aortic stenosis; Current Intracardiac LA or LV thrombus; Severe proximal three-vessel or left main coronary artery disease without revascularization; Hemodynamic instability; Unstable angina; Recent stroke or transient ischemic attack (within the last 3 months); Known inadequate external defibrillation; LVEF < 20% (most recent assessment; must be within 180 days of consent); LVEDD >70 mm (most recent assessment; must be within 180 days of consent); Patients who cannot read or write; Expected survival < 1 year; Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period; Inability or unwillingness to provide informed consent to participate in the study; Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit; Circumstances that may prevent data collection or completion of specified follow-up visits; Contraindication for temporary suspension of oral/systemic anticoagulation; Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads; Known obstructed or restricted pathway into the mediastinum for the Atala™ lead; Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis).

ClinicalTrials.gov NCT07324031