Clinical trial NCT05633394: Subcostal Temporary Extravascular Pacing V Study
Official title: Subcostal Temporary Extravascular Pacing V (STEP V) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conduction Defect
Keywords: Temporary Ventricular Pacing
Extravascular
Lead sponsor: AtaCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 50
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 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.

Eligibility criteria: Inclusion criteria

1. At least 18 years old
2. 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

1. BMI ≥ 35 kg/m2
2. Septic shock
3. Severe anemia
4. Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
5. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
6. Participation in any concurrent clinical study without prior written approval from the Sponsor
7. Inability or unwillingness to provide informed consent to participate in the Study

   Known prior history for any of the following:
8. Median or partial sternotomy
9. Acute coronary syndrome within past 90 days
10. NYHA Functional Classification IV within past 90 days
11. Surgically corrected congenital heart disease (not including catheter-based procedures)
12. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and silicone
13. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
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 which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
16. Any conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
17. Pericardial disease, pericarditis and mediastinitis
18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
19. FEV1 \< 1 liter

Primary outcomes:
measure: Freedom from ADEs
timeFrame: Up to 2 days post-insertion
measure: Pacing Capture Threshold (mA or V)
timeFrame: Up to 2 days post-insertion
measure: Impedance (Ohms)
timeFrame: Up to 2 days post-insertion
measure: Sensed R-Wave Amplitude (mV)
timeFrame: Up to 2 days post-insertion
Secondary outcomes:
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: