Subcostal Temporary Extravascular Pacing V Study (STEP V)

AtaCor Medical

Status

Completed

Conditions

Conduction Defect

Treatments

Device: AtaCor StealthTrac Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT05633394

DOC-10235

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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