Pacertool Early Feasibility Study - Safety and Performance

NCT06103539 | Unknown DMC

• 1 other identifier: PaCRTool-Study 012023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Dyssynchrony; Medical Device Performance

Keywords

Early feasibility observational study

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Safety Outcome Measures (PreSens-Catheter):

  30 days

• Performance Outcome Measures (PreSens-Catheter)

  4 hours

• Performance Outcome Measures (PreSens-Catheter and PACER Software):

  4 hours

Other Outcomes (1)

• iv) Exploratory Performance Outcome Measures (PreSens-Catheter and PACER Software):

  4 hours

Study Arms (1)

1

Patients with an indication for left heart catheterization or cardiac resynchornization therapy

Device: Cardiac catheterization and evoked response to cardiac stimulation

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacertool AS: lead

Study Sites (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

Related Publications (2)

• 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.

  PMID: 36186985 BACKGROUND

• 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.

  PMID: 34514746 BACKGROUND

MeSH Terms

Interventions

Cardiac Catheterization

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Tamaz Shaburishvili, MD

  Tbilisi Heart and Vascular Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Henrik Odland, MD, PhD

CONTACT

+4790509944; hho@pacertool.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 30, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

GE (1)