Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

Ventricular Tachycardia Clinical Trial

— PASS PULL  

Official title:

Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099289
• Other study ID #: DOC-10154
• Status: Completed
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: AtaCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 31, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrhythmia
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• AtaCor EV-ICD Lead
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
AtaCor Medical, Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SADEs	Incidence of Serious Adverse Device Effects (SADEs)	Up to 10 days post-procedure
Primary	Rate of Insertion Success	Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs	Procedure
Secondary	Functionality - Lowest Defibrillation Conversion Energy	Lowest Defibrillation Conversion Energy (J)	Procedure
Secondary	Observational: Incidence of ADEs	Incidence of Adverse Device Effects (ADEs), Overall and Individual	Up to 10 days post-procedure