Clinical trial NCT06103539: Pacertool Early Feasibility Study - Safety and Performance
Official title: Pacertool-Study - Safety and Performance of the Presens-Catheter and the Pacer Software
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Dyssynchrony
Medical Device Performance
Keywords: Early feasibility observational study
Lead sponsor: Pacertool AS
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is adult patients (\>18years) with (part I) an indication for left heart catheterization, or (part I and II) a clinical syndrome of heart failure with reduced ejection fraction and normal sinus rhythm with signs of ventricular electrical conduction defects in the heart, who meets standard criteria for implantation of a cardiac resynchronization therapy device.

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 reported outcome data from using the PreSens-Catheter and PACER Software during cardiac catheterization and Cardiac Resynchronization Therapy (CRT) device implantation procedures. Subjects with indication for arterial catheterization and CRT will be included.

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 therapy device implantation to demonstrate acute safety and performance of the PreSens-Catheter and the PACER Software for Td measurements.
2. Safety and performance assessment: At least 35 patients with an indication for CRT implantation according to standard of care to demonstrate acute safety and performance of using the PreSens-Catheter and the PACER Software to measure Td and detect Synergy and Dyssynergy from multisite stimulation, and its utility to deliver measurements for the discrimination of two clinical cardiac reverse volumetric remodeling phenotypes based on Synergy and Dyssynergy in the targeted population.

Subjects will be followed for the duration of the procedure up to 24 hours for any serious adverse events, and subjects receiving a CRT device will be followed for 30 days follow-up for procedure or device-related events and for up to 6 months for cardiac volumetric remodeling phenotyping.

Clinical outcomes: Clinical outcome will be measured as Safety for the placement of the PreSens-Catheter, safety for the PreSens-Catheter and PACER Software combined for the measurement of Td and detection of Synergy/ Dyssynergy from stimulation, and diagnostic/ predictive performance of the PreSens-Catheter and PACER Software with the measurement of end-systolic volume at 6-months follow-up.

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

Primary outcomes:
measure: Primary Safety Outcome (PreSens-Catheter):
timeFrame: 24 hours
measure: Primary Safety Outcome Measures (PreSens-Catheter and PACER Software):
timeFrame: 4 hours
measure: Primary Performance Outcome Measures (PreSens-Catheter and PACER Software):
timeFrame: 6 months
Secondary outcomes:
measure: Safety Outcome Measures (PreSens-Catheter):
timeFrame: 30 days
measure: Performance Outcome Measures (PreSens-Catheter)
timeFrame: 4 hours
measure: Performance Outcome Measures (PreSens-Catheter and PACER Software):
timeFrame: 4 hours
Other outcomes:
measure: iv) Exploratory Performance Outcome Measures (PreSens-Catheter and PACER Software):
timeFrame: 4 hours
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
Study officials:
affiliation: Tbilisi Heart and Vascular Clinic
name: Tamaz Shaburishvili, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Odland HH, Holm T, Cornelussen R, Kongsgard E. Determinants of the time-to-peak left ventricular dP/dt (Td) and QRS duration with different fusion strategies in cardiac resynchronization therapy. Front Cardiovasc Med. 2022 Sep 15;9:979581. doi: 10.3389/fcvm.2022.979581. eCollection 2022.
citation: Odland HH, Villegas-Martinez M, Ross S, Holm T, Cornelussen R, Remme EW, Kongsgard E. Shortening of time-to-peak left ventricular pressure rise (Td) in cardiac resynchronization therapy. ESC Heart Fail. 2021 Dec;8(6):5222-5236. doi: 10.1002/ehf2.13601. Epub 2021 Sep 12.