Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AtaCor Medical, Inc.
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Freedom from major ADEs
Study Overview
Brief Summary
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation.
The objectives of the study are to: 1) preliminarily validate safety and effectiveness of the Atala™ lead as a permanent ICD lead when used with a compatible ICD pulse generator, 2) evaluate suitability of clinical study testing methods and 3) inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation.
Detailed Description
The primary safety endpoint is freedom from major Adverse Device Effects (ADEs) through 3-months. The primary performance endpoint is successful induced ventricular arrhythmia (IVA) test in the final system configuration.
Up to three (3) Investigational Sites will participate with up to 35 Subjects enrolled in the study. Subjects who meet current indications for ICD therapy will be eligible for participation. Eligible Subjects will receive an Atala™ lead connected to a commercially available ICD positioned in a left pectoral or left lateral location.
The Atala™ lead will be connected to a compatible ICD pulse generator and tested to verify appropriate sensing and defibrillation. Abbreviated IVA testing will be performed at the 3-month follow-up visit to verify continued sensing and defibrillation effectiveness. Starting at 6 months, Subjects will be followed every 6 months until the study is closed. The study is expected to remain open for at least 3 years.
Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 3-month visit.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Participation in any concurrent clinical study without prior written approval from the Sponsor
- •Inability or unwillingness to provide informed consent to participate in the Study
- •Any known conditions which may complicate the AtaCor EV-ICD Lead System implant procedure or prevent the subject from completing protocol testing through the 3-month follow-up visit
- •Circumstances that may prevent data collection or completion of specified follow-up visits
- •Allergies to any device materials listed in the Instructions for Use (IFU)
- •Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
- •Known history of lung disease with FEV1 < 1.0 Liter
- •Device Related:
- •Presence or planned use of medical devices that introduce current into the body (e.g., pacemaker, LVAD, neurostimulator, etc.)
- •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, or neurostimulator
- •Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
- •Any known need for future MRI
- •Anatomy Related:
- •BMI ≥ 35 kg/m2
- •Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
- •Prior sternotomy of any type, including but not limited to median, mini or clamshell
- •Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
- •Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) and associated with displacement of the heart or lungs or impeded mediastinal access.
- •History of thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV-ICD Lead 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:
- •Subjects who require permanent bradycardia pacing or cardiac resynchronization therapy
- •NYHA IV functional class in past 90 days
- •Inotropic therapy in past 180 days
- •Known history of pericardial disease, pericarditis or mediastinitis
- •Patients with a medical condition that precludes them from undergoing 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 6 months)
- •Known inadequate external defibrillation
- •LVEF < 20%
- •LVEDD >70 mm
Arms & Interventions
AtaCor EV-ICD Lead System
Subjects implanted with the Atala™ lead
Intervention: Atala™ lead (Device)
Outcomes
Primary Outcomes
Freedom from major ADEs
Time Frame: Through 3 months post-implant
Freedom from major Adverse Device Effects (ADEs)
Successful IVA Test
Time Frame: At the time of procedure
Successful induced ventricular arrhythmia (IVA) test in the final system configuration
Secondary Outcomes
No secondary outcomes reported