Status:
UNKNOWN
Pacertool Early Feasibility Study - Safety and Performance
Lead Sponsor:
Pacertool AS
Conditions:
Heart Failure With Reduced Ejection Fraction
Dyssynchrony
Eligibility:
All Genders
18-80 years
Brief Summary
The study is a non-randomized, two-part, open label, prospective single-site, single arm, safety and performance study. The study is designed to collect acute and long-term clinical data and user repo...
Detailed Description
The study consists of two parts: 1. Initial safety assessment: at least 5 patients undergoing coronary angiography or left heart catheterization and 5 patients undergoing cardiac resynchronization th...
Eligibility Criteria
Inclusion
- Part I:
- Subject has an indication for coronary angiography or left heart catheterization or cardiac resynchronization therapy.
- QRS duration between 90-150ms.
- Subject is ≥ 18 years old.
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the clinical study.
- Willing and able to give informed consent.
- Part II:
- Subject in sinus rhythm with an indication for implantation of a Cardiac Resynchronization Device (Appendix I)
- NYHA Class II-IV (Ambulatory IV)
- EF\<35%
- QRS duration \>120ms.
- Subject is ≥ 18 years old.
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the clinical study.
- Willing and able to give informed consent.
Exclusion
- ¨
- Subject has unstable angina/ acute coronary ischemia/ infarction
- Previous myocardial infraction (\<6 months)
- History of blood clothing or bleeding disease
- Prior history of documented cerebral infarction, TIA or systemic embolism (excluding a postoperative DVT)
- Subject has an arterial unstable aneurysm
- Subject has severe peripheral vascular disease
- Subject has an artificial aortic or mitral valve replacement
- Subject has severe aortic valve disease
- Subject has a clinically significant infection (bacteriemia or sepsis)
- Subject has contraindications to anticoagulation
- Patients with a serious allergy to drugs necessary for the procedure such as anticoagulants and protamine
- Subject has left atrial/ ventricular thrombus
- Patients with severe vascular obstructions in the desired/ presumed insertion path of the catheter
- Significant or symptomatic hypotension
- NYHA class IV (hospitalized), severe circulation instability or shock
- Ongoing/ persistent atrial arrythmias
- History of Rheumatic fever
- Subject has sensitivity to contrast media
- Contraindications to CT or fluoroscopy
- Distorted cardiac anatomy due to congenital heart disease
- Pregnant or possibly pregnant
- Not eligible for thoracotomy procedures
- Life expectancy \<1 years
- Any other condition that, in the judgement of the investigator, makes the subject a poor candidate for this procedure, the study or compliance with the protocol (includes addictive disease, extensive travel away from the research center)
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements of this study
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06103539
Start Date
December 1 2023
End Date
December 30 2024
Last Update
October 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159