Status:
COMPLETED
Subcostal Temporary Extracardiac Pacing II Study
Lead Sponsor:
AtaCor Medical, Inc.
Conditions:
Conduction Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used ...
Detailed Description
Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. Following StealthTrac Lead insertion, each subjec...
Eligibility Criteria
Inclusion
- Indicated for closed-chest cardiac invasive procedure that does not require full systemic anticoagulation during the procedure.
- Examples of such procedures include: transcatheter valve replacement, balloon valvuloplasty, implantable cardioverter-defibrillator (ICD) implantation, permanent pacemaker implantation and pacing lead extractions/revisions.
- Physically and mentally capable of providing informed consent and at least 18 years of age or of legal age to provide consent as required by local and national requirements.
Exclusion
- History of a prior sternotomy (median or partial);
- History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
- History of significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;
- History of pericardial disease, pericarditis or mediastinitis;
- History of chronic obstructive pulmonary disease (COPD);
- NYHA functional classification IV at the time of enrollment;
- History of congenital heart disease;
- Patients with circumstances that prevent data collection or follow-up;
- BMI \> 35 kg/m2;
- Contraindication to glucocorticoid medication;
- History of allergies to any study devices; and
- Participation in any concurrent study without prior, written approval from the Sponsor.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04374929
Start Date
July 28 2020
End Date
May 14 2021
Last Update
June 11 2021
Active Locations (2)
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1
Christchurch Hospital
Christchurch, New Zealand
2
Sanatorio Italiano
Asunción, Paraguay