Pacertool Early Feasibility Study - Safety and Performance

Launched by PACERTOOL AS · Oct 23, 2023

Keywords

ClinConnect Summary

The Pacertool Early Feasibility Study is a clinical trial aimed at evaluating the safety and performance of a new medical device called the PreSens-Catheter along with PACER Software. This study focuses on patients who have heart failure with a weakened heart function and may benefit from a procedure called cardiac catheterization or the implantation of a Cardiac Resynchronization Therapy (CRT) device. The trial will collect both short-term and long-term data to understand how well the device works and how it impacts patients' health.

To be eligible for this study, participants must be at least 18 years old and have specific heart conditions, such as a certain heart rhythm and reduced heart function. They should be willing to take part in regular check-ups throughout the study. However, some individuals may not qualify due to other health issues, such as recent heart attacks or severe bleeding disorders. If eligible, participants can expect to undergo standard heart procedures while providing important information about their experience, which will help researchers assess the device's effectiveness for future patients. This study is currently not recruiting participants, but it is a significant step in exploring new treatment options for heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:¨
• • 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