Status:
COMPLETED
Subcostal Temporary Extracardiac Pacing Study
Lead Sponsor:
AtaCor Medical, Inc.
Conditions:
Conduction Defect
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events. Performance will b...
Detailed Description
Enrolled Subjects will have both a market-released transvenous pacing lead and investigational StealthTrac Temporary Pacing Lead placed and evaluated. During the placement procedure, diagnostic echoca...
Eligibility Criteria
Inclusion
- Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.
- Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.
- Physically and mentally capable of providing informed consent.
- At least 18 years of age or of legal age to provide consent as required by local and national requirements.
Exclusion
- Contraindicated or clinically unsuitable for transvenous lead placement;
- Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
- 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 the thorax (e.g., pectus excavatum), 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, including conditions that prevent ambulation and testing in multiple postures;
- BMI ≥ 35 kg/m2;
- History of allergies to any study device components;
- Pregnant or lactating (current or anticipated during study follow up); and
- Participation in any concurrent study without prior, written approval from the Sponsor.
Key Trial Info
Start Date :
August 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04096365
Start Date
August 25 2019
End Date
November 7 2019
Last Update
February 3 2021
Active Locations (1)
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1
Sanatorio Italiano
Asunción, Paraguay