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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.
The study consists of two parts:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with an indication for left heart catheterization or cardiac resynchornization therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac catheterization and evoked response to cardiac stimulation | Device | Cardiac catheterization with a combined elecrtophysiology and pressure sensing catheter to perform multisite stimulation and measure the evoked pressure response in a connected software. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome (PreSens-Catheter): | The primary safety outcome is the incidence of procedure or device-related Serious Adverse Events (SAEs and SADEs) on the day of the procedure | 24 hours |
| Primary Safety Outcome Measures (PreSens-Catheter and PACER Software): | The primary safety outcome of the PreSens-Catheter and PACER Software is the incidence of false positive readings of Synergy resulting from multisite stimulation from PreSens-Catheter in patients with narrow QRS and false negative readings (Dyssynergy) compared to the resulting reading from pacing with the CRT device. | 4 hours |
| Primary Performance Outcome Measures (PreSens-Catheter and PACER Software): | Detection of Synergy and Dyssynergy to phenotype patients for the prediction of reverse volumetric remodeling response after 6 months of Cardiac Resynchronization Therapy. Outcome is based on the change in End-Systolic Volume (ESV) from baseline to 6 months follow-up in the respective phenotypes. The study is powered to detect a ΔESV of 30% points difference between the Synergy and Dyssynergy characterized patients after 6 months of Cardiac Resynchronization Therapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measures (PreSens-Catheter): | Percentage of subjects experiencing a composite safety event. The composite safety outcome (CSO) defined as the incidence of events which are device- or procedure-related | 30 days |
| Performance Outcome Measures (PreSens-Catheter) |
| Measure | Description | Time Frame |
|---|---|---|
| iv) Exploratory Performance Outcome Measures (PreSens-Catheter and PACER Software): | (a) Percentage of subjects experiencing (from each position in the left heart): (i) Demonstration of prolongation of Td with pacing off a proximal electrode (ii) Demonstration of prolongation of Td with pacing off a distal electrode (iii) Demonstration of shortening of Td (Synergy) with pacing from electrodes from both electrode groups (distal and proximal) compared to the shortest Td with pacing from either distal or proximal electrode. (iv) Demonstration of shortening of Td (Synergy) with pacing from electrodes from both electrode groups (distal and proximal) compared to baseline Td in patients with QRS duration above 130ms and below or equal to 130ms. (v) Demonstration of prolongation of Td (Dyssynergy) with biventricular pacing (negative responder, true negative result) compared to baseline Td in patients with QRS duration above 130ms and ≤130ms. (vi) Demonstration of a short Td (≤120ms) at baseline in patients with a QRS duration ≤130ms and long Td (>120ms) at baseline in patient |
Inclusion Criteria:
Part I:
Part II:
Exclusion Criteria:¨
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Henrik Odland, MD, PhD | Contact | +4790509944 | hho@pacertool.com |
| Name | Affiliation | Role |
|---|---|---|
| Tamaz Shaburishvili, MD | Tbilisi Heart and Vascular Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart and Vascular Clinic | Tbilisi | 0159 | Georgia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36186985 | Background | 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. | |
| 34514746 | Background |
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| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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a) The proportion of subjects that achieve Acute Procedural Success (APS) defined as the correct insertion and placement of the PreSens-Catheter within the heart with confirmed readings/ recordings from the catheter and imaged with fluoroscopy in two planes, in at least one of the defined positions depending on available access sheets (on an intention-to-treat basis). b) The proportion of subjects that had the PreSens-Catheter placed in the left heart with the intention to place the catheter with the distal electrodes in three different positions (anterior, lateral, posterior); number of positions achieved in each patient. c) Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree") [Time Frame: During Procedure]. d) Acute product performance will be quantitatively and qualitatively evaluated during the procedure. |
| 4 hours |
| Performance Outcome Measures (PreSens-Catheter and PACER Software): | The proportion of subjects that achieve Acute Procedural Success (APS) defined as successful placement of the PreSens-Catheter in the heart and measurement of Td (time to peak exponential pressure rise (dP/dt)) with the PACER Software; with stimulation from the PreSens-Catheter and from the CRT (with the rate of agreement) with the PreSens-Catheter placed in at least two out of three defined positions. (CRT recipients only). | 4 hours |
| 4 hours |
| 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. |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |