CompletedNot Applicable

Subcostal Temporary Extravascular Pacing V Study

Paraguay29 participantsStarted 2023-01-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. At least 18 years old
✓. Subjects indicated for closed-chest cardiac invasive procedure, including:

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
✕. Median or partial sternotomy

What they're measuring

Freedom from ADEs

Timeframe: Up to 2 days post-insertion

Pacing Capture Threshold (mA or V)

Timeframe: Up to 2 days post-insertion

Impedance (Ohms)

Timeframe: Up to 2 days post-insertion

Sensed R-Wave Amplitude (mV)

Timeframe: Up to 2 days post-insertion

Trial details

NCT IDNCT05633394

SponsorAtaCor Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-29

View on ClinicalTrials.gov More Conduction Defect trials