Subcostal Temporary Extravascular Pacing V (STEP V) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AtaCor Medical, Inc.
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Freedom from ADEs
Study Overview
Brief Summary
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period.
Detailed Description
The primary safety objective is freedom from Adverse Device Effects (ADE). The primary performance objective is summary statistics for pacing capture threshold, impedance, and sensed R-wave amplitude with the StealthTrac Lead from insertion through removal.
Up to three (3) Investigational Sites will participate with up to 50 subjects enrolled in the study. Subjects indicated for closed-chest cardiac invasive procedures will be eligible for participation. Subjects undergoing a qualifying index procedure will have a Model AC-101400 StealthTrac Lead inserted and evaluated over the follow-up period. Subject participation is expected to be 2 days with the Study Lead inserted, plus 30 days post lead removal. A 30 day (+/-3 days) post-removal follow-up will also be performed to document any latent adverse events. Subjects remain enrolled until completion of the 30-Day Follow Up.
The maximum duration for study participation is 33 days. Study duration estimated to be 3 years after the first study enrollment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years old
- •Subjects indicated for closed-chest cardiac invasive procedure, including:
- •Transarterial transcatheter aortic valve implantation (TAVI)
- •Transarterial balloon aortic valvuloplasty (BAV)
- •Cardiovascular implantable electronic device (CIED) pulse generator replacement
- •Cardiovascular implantable electronic device (CIED) lead extraction or revision
Exclusion Criteria
- •BMI ≥ 35 kg/m2
- •Septic shock
- •Severe anemia
- •Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
- •Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
- •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
- •Known prior history for any of the following:
- •Median or partial sternotomy
- •Acute coronary syndrome within past 90 days
- •NYHA Functional Classification IV within past 90 days
- •Surgically corrected congenital heart disease (not including catheter-based procedures)
- •Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
- •Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
- •Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- •Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- •Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
- •Pericardial disease, pericarditis and mediastinitis
- •Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
- •FEV1 < 1 liter
Arms & Interventions
AtaCor EV Temporary Pacing Lead System
Subjects implanted with the AtaCor StealthTrac Lead Model AC-101400
Intervention: AtaCor StealthTrac Lead (Device)
Outcomes
Primary Outcomes
Freedom from ADEs
Time Frame: Up to 2 days post-insertion
Freedom from Adverse Device Effects (ADE)
Sensed R-Wave Amplitude (mV)
Time Frame: Up to 2 days post-insertion
Summary statistics for sensed R-wave amplitude with the StealthTrac Lead from insertion through removal
Pacing Capture Threshold (mA or V)
Time Frame: Up to 2 days post-insertion
Summary statistics for pacing capture threshold with the StealthTrac Lead from insertion through removal
Impedance (Ohms)
Time Frame: Up to 2 days post-insertion
Summary statistics for impedance with the StealthTrac Lead from insertion through removal
Secondary Outcomes
No secondary outcomes reported