Clinical trial NCT05099289: Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
Official title: Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrhythmia
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: Ventricular Defibrillation
Lead sponsor: AtaCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.

Detailed description: The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.

Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for enrollment.

Eligibility criteria: Inclusion criteria

1. At least 18 years old
2. Indicated for de novo or replacement ICD procedure

Exclusion criteria

1. NYHA IV functional class
2. BMI ≥ 35 kg/m2
3. Inotropic therapy in past 180 days
4. Subjects with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing
5. Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
6. Subjects on anticoagulation/antiplatelet therapy that cannot be temporarily discontinued for the procedure
7. Logistical or safety related circumstances that may prevent data collection or follow-up
8. Participation in any concurrent clinical study without prior written approval from the Sponsor
9. Inability to give an informed consent to participate in the Study

   Known prior history for any of the following:
10. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead as assessed from available CT or Echocardiography.
11. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
12. Median or partial sternotomy
13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
14. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
15. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
16. Pericardial disease, pericarditis and mediastinitis
17. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
18. FEV1 \< 1.0 Liter
19. Surgically corrected congenital heart disease (not including catheter-based procedures)
20. Allergies to the device materials as listed in the Instructions for Use (IFU)

Primary outcomes:
measure: Incidence of SADEs
timeFrame: Up to 10 days post-procedure
measure: Rate of Insertion Success
timeFrame: Procedure
Secondary outcomes:
measure: Functionality - Lowest Defibrillation Conversion Energy
timeFrame: Procedure
measure: Observational: Incidence of ADEs
timeFrame: Up to 10 days post-procedure
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: AtaCor Medical, Inc.
name: Martin C Burke, DO
role: PRINCIPAL_INVESTIGATOR
References: