N/A
N=12
Subcostal Temporary Extracardiac Pacing Study
Conduction Defect
Bottom Line
View on ClinicalTrials.gov: NCT04096365 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Subcostal Temporary Extracardiac Pacing Lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- AtaCor Medical, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect |
2 | — |
| PRIMARY Performance Outcome: Mean Pacing Capture Threshold (V) |
4.1; 5.6; 7.0 | — |
| PRIMARY Performance Outcome: Mean Pacing Impedance (Ohms) |
557; 320; 266 | — |
| PRIMARY Performance Outcome: Mean R-Wave Amplitude (mV) |
4.9; 2.7; 2.6 | — |
| PRIMARY Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity |
97.85; 98.9 | — |
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 be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04096365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.