Heart Failure With Reduced Ejection FractionNCT06103539
Pacertool Early Feasibility Study - Safety and Performance
An observational study of Heart Failure With Reduced Ejection Fraction and Dyssynchrony, run by Pacertool AS at 1 site in Georgia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Dyssynchrony, Medical Device Performance
- What is being tested?
- Cardiac catheterization and evoked response to cardiac stimulation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGeorgia
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pacertool-Study - Safety and Performance of the Presens-Catheter and the Pacer Software
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.
Read the detailed description
The study consists of two parts:
- 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.
- 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.
- Being tested
- Cardiac catheterization and evoked response to cardiac stimulation
- Keywords
- Early feasibility observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac catheterization and evoked response to cardiac stimulationDevice
Cardiac catheterization with a combined elecrtophysiology and pressure sensing catheter to perform multisite stimulation and measure the evoked pressure response in a connected software.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with an indication for left heart catheterization or cardiac resynchornization therapy Receives: Device: Cardiac catheterization and evoked response to cardiac stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 30 days
Performance Outcome Measures (PreSens-Catheter)
- 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.
Measured: 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).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacertool AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamaz Shaburishvili, MD, Principal investigator, Tbilisi Heart and Vascular Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103539
- Sponsor's protocol ID
- PaCRTool-Study 012023
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36186985Odland 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.
PubMed 34514746
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacertool-Study - Safety and Performance of the Presens-Catheter and the Pacer Software
- ClinicalTrials.gov ID
- NCT06103539
- Acronym / sponsor ID
- PaCRTool-Study 012023
- Keywords
- Early feasibility observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pacertool ASIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Cardiac catheterization and evoked response to cardiac stimulationPatients with an indication for left heart catheterization or cardiac resynchornization therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac catheterization and evoked response to cardiac stimulationCardiac catheterization with a combined elecrtophysiology and pressure sensing catheter to perform multisite stimulation and measure the evoked pressure response in a connected software. | Device | 1 |
Primary outcome
Primary Safety Outcome (PreSens-Catheter):
Time frame: 24 hours
The primary safety outcome is the incidence of procedure or device-related Serious Adverse Events (SAEs and SADEs) on the day of the procedure
Primary Safety Outcome Measures (PreSens-Catheter and PACER Software):
Time frame: 4 hours
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.
Primary Performance Outcome Measures (PreSens-Catheter and PACER Software):
Time frame: 6 months
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.
3 secondary outcomes
Safety Outcome Measures (PreSens-Catheter):
Time frame: 30 days
Performance Outcome Measures (PreSens-Catheter)
Time frame: 4 hours
Performance Outcome Measures (PreSens-Catheter and PACER Software):
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 36186985Odland 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.
- Background: PubMed 34514746Odland 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamaz Shaburishvili, MD principal investigator
Tbilisi Heart and Vascular Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction and Dyssynchrony, run by Pacertool AS at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Henrik Odland, MD, PhD (+4790509944, hho@pacertool.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome (PreSens-Catheter): (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103539, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.