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Conduction Defect

Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

Sponsored by AtaCor Medical, Inc.

About this trial

Last updated 2 years ago

Study ID

DOC-10219

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.

What are the participation requirements?

Yes

Inclusion Criteria

1. At least 18 years old

2. Subjects who:

- Are undergoing one of the following planned (non-urgent) procedures that are associated with the potential need for temporary bradycardia pacing:
- 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
- Subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent
No

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

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

Locations

Location

Status

Recruiting