Status:
COMPLETED
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
Lead Sponsor:
AtaCor Medical, Inc.
Conditions:
Ventricular Arrhythmia
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up t...
Detailed Description
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of...
Eligibility Criteria
Inclusion
- At least 18 years old
- Indicated for de novo or replacement ICD procedure
Exclusion
- NYHA IV functional class
- BMI ≥ 35 kg/m2
- Inotropic therapy in past 180 days
- Subjects who require continual ventricular pacing
- Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
- Planned MRI within the study period
- Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
- Logistical or safety related circumstances that may prevent data collection or follow-up
- Participation in any concurrent clinical study without prior written approval from the Sponsor
- Inability to give an informed consent to participate in the Study
- Known prior history for any of the following:
- 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
- Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
- Median or partial sternotomy
- Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
- Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
- Pericardial disease, pericarditis and mediastinitis
- Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- FEV1 \< 1.0 Liter
- Surgically corrected congenital heart disease (not including catheter-based procedures)
- Allergies to the device materials as listed in the Instructions for Use (IFU)
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05352776
Start Date
May 18 2022
End Date
October 20 2022
Last Update
August 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanatorio Italiano
Asunción, Paraguay