Cardiac Hemodynamics During Left Ventricular Assist

NCT06115096 | Recruiting

• 1 other identifier: FlowVAD
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to exploratively investigate intracardiac geometry and hemodynamics in patients with ongoing HeartMate 3-therapy in the Swedish Southeast Healthcare region. The main question it aims to answer is: \- How do different flow levels in the HeartMate 3 left ventricular assist system influence intracardiac geometry and hemodynamics? Participating research subjects are called upon to undergo three followed photon-counting CT scans, as well as certain echocardiographic imaging, all in one session. The research subject's HeartMate device is connected to software that allows for variations in the pump's flow between these image collections. Analyzed variables includes three-dimensional geometry, CFD-computed parameters such as blood velocity, pressure, turbulence, and blood stasis. The variables are related with device settings and, alongside, selected echocardiographic measurements and patient details such as age, BMI, and diagnostic codes for both method validation and comprehensive perspective.

Conditions

Heart Failure

Keywords

Left ventricular assist device (LVAD); Computed tomography (CT); Photon-counting Computed tomography (PCCT); Hemodynamics; Computational fluid dynamics (CFD)

Outcome Measures

Primary Outcomes (2)

• Hemodynamic Variables

  Intracardiac hemodynamic variables such as blood flow velocity maps (m/s), absolute pressure maps (mmHg), turbulence kinetic energy maps (TKE), and blood stasis maps will be calculated both intracardiac and in the pump's outflow graft. It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.

  Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.

• Intracardiac Geometry

  Intracardiac volumes (ml) will be calculated for the left atrium, left ventricle, right ventricle and right atrium over the cardiac cycle (20 phases). It is essential to clarify that due to the exploratory nature of the research and the intricate dynamics inherent to both using numerical frameworks for calculating intracardiac hemodynamic maps and the dynamic geometric nature of time-resolved CT, all variables at the study onset are not pre-defined. As the analysis progresses, and the full depth of the data becomes apparent, additional variables may be identified and incorporated. Subsequent decision-making process relating to the inclusion or exclusion of these newly discovered variables will be rigorously documented to ensure transparency and robustness in the study approach.

  Observations are made at a single point in time. No follow-up of outcomes are analyzed. Post-processing and analysis of both hemodynamic and geometric data are performed through study completion, an average of 1 year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All HeartMate 3 patients within the Swedish Southeastern healthcare region, encompassing Östergötland, Jönköping, and Kalmar counties, who meet the inclusion criteria and none of the exclusion criteria, will be invited to participate in this study during 2023. Screening for inclusion is conducted by the LVAD-responsible physicians within the Cardiology Department at Linköping University Hospital.

You may qualify if:

• Connected to Linköping University Hospital ((situated in the Swedish Southeastern healthcare region)
• Treatment with HeartMate 3 and implanted for \> 6 months ago
• Age \>18 years.

You may not qualify if:

• Reduced kidney function (eGFR below 45 ml/min/1.73m2).
• Known iodine contrast allergy
• In case of untreated manifest hyperthyroidism
• In case of suspected/newly diagnosed thyroid cancer where radioiodine examination/treatment may be relevant
• Myasthenia Gravis
• Ongoing pregnancy

Sponsors & Collaborators

• Region Östergötland: lead
• Linkoeping University: collaborator

Study Sites (1)

Linköping University Hospital

Linköping, Östergötland County, 58185, Sweden

RECRUITING

Related Publications (13)

• Goldstein DJ, Naka Y, Horstmanshof D, Ravichandran AK, Schroder J, Ransom J, Itoh A, Uriel N, Cleveland JC Jr, Raval NY, Cogswell R, Suarez EE, Lowes BD, Kim G, Bonde P, Sheikh FH, Sood P, Farrar DJ, Mehra MR. Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiol. 2020 Apr 1;5(4):411-419. doi: 10.1001/jamacardio.2019.5323.

  PMID: 31939996 BACKGROUND

• Gupta V, Lantz J, Henriksson L, Engvall J, Karlsson M, Persson A, Ebbers T. Automated three-dimensional tracking of the left ventricular myocardium in time-resolved and dose-modulated cardiac CT images using deformable image registration. J Cardiovasc Comput Tomogr. 2018 Mar-Apr;12(2):139-148. doi: 10.1016/j.jcct.2018.01.005.

  PMID: 29402736 BACKGROUND

• Imamura T, Chung B, Nguyen A, Sayer G, Uriel N. Clinical implications of hemodynamic assessment during left ventricular assist device therapy. J Cardiol. 2018 Apr;71(4):352-358. doi: 10.1016/j.jjcc.2017.12.001. Epub 2017 Dec 26.

  PMID: 29287808 BACKGROUND

• Imamura T, Jeevanandam V, Kim G, Raikhelkar J, Sarswat N, Kalantari S, Smith B, Rodgers D, Besser S, Chung B, Nguyen A, Narang N, Ota T, Song T, Juricek C, Mehra M, Costanzo MR, Jorde UP, Burkhoff D, Sayer G, Uriel N. Optimal Hemodynamics During Left Ventricular Assist Device Support Are Associated With Reduced Readmission Rates. Circ Heart Fail. 2019 Feb;12(2):e005094. doi: 10.1161/CIRCHEARTFAILURE.118.005094.

  PMID: 30704291 BACKGROUND

• Lantz J, Gupta V, Henriksson L, Karlsson M, Persson A, Carlhall CJ, Ebbers T. Intracardiac Flow at 4D CT: Comparison with 4D Flow MRI. Radiology. 2018 Oct;289(1):51-58. doi: 10.1148/radiol.2018173017. Epub 2018 Jun 26.

  PMID: 29944089 BACKGROUND

• Lantz J, Henriksson L, Persson A, Karlsson M, Ebbers T. Patient-Specific Simulation of Cardiac Blood Flow From High-Resolution Computed Tomography. J Biomech Eng. 2016 Dec 1;138(12). doi: 10.1115/1.4034652.

  PMID: 27618494 BACKGROUND

• Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.

  PMID: 27959709 BACKGROUND

• Mehra MR, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, Walsh MN, Milano CA, Patel CB, Hutchins SW, Ransom J, Ewald GA, Itoh A, Raval NY, Silvestry SC, Cogswell R, John R, Bhimaraj A, Bruckner BA, Lowes BD, Um JY, Jeevanandam V, Sayer G, Mangi AA, Molina EJ, Sheikh F, Aaronson K, Pagani FD, Cotts WG, Tatooles AJ, Babu A, Chomsky D, Katz JN, Tessmann PB, Dean D, Krishnamoorthy A, Chuang J, Topuria I, Sood P, Goldstein DJ; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. 2019 Apr 25;380(17):1618-1627. doi: 10.1056/NEJMoa1900486. Epub 2019 Mar 17.

  PMID: 30883052 BACKGROUND

• Ohlsson L, Moreira ADL, Back S, Lantz J, Carlhall CJ, Persson A, Hedman K, Chew MS, Dahlstrom N, Ebbers T. Enhancing students' understanding of cardiac physiology by using 4D visualization. Clin Anat. 2023 Apr;36(3):542-549. doi: 10.1002/ca.24009. Epub 2023 Feb 6.

  PMID: 36695446 BACKGROUND

• Rosenbaum AN, Geske JB, Stulak JM, Kushwaha SS, Clavell AL, Behfar A. Left Ventricular Hemodynamics and Relationship With Myocardial Recovery and Optimization in Patients Supported on CF-LVAD Therapy. J Card Fail. 2022 May;28(5):799-806. doi: 10.1016/j.cardfail.2021.12.008. Epub 2021 Dec 17.

  PMID: 34929296 BACKGROUND

• Stainback RF, Estep JD, Agler DA, Birks EJ, Bremer M, Hung J, Kirkpatrick JN, Rogers JG, Shah NR; American Society of Echocardiography. Echocardiography in the Management of Patients with Left Ventricular Assist Devices: Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2015 Aug;28(8):853-909. doi: 10.1016/j.echo.2015.05.008. No abstract available.

  PMID: 26239899 BACKGROUND

• Uriel N, Colombo PC, Cleveland JC, Long JW, Salerno C, Goldstein DJ, Patel CB, Ewald GA, Tatooles AJ, Silvestry SC, John R, Caldeira C, Jeevanandam V, Boyle AJ, Sundareswaran KS, Sood P, Mehra MR. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure. Circulation. 2017 May 23;135(21):2003-2012. doi: 10.1161/CIRCULATIONAHA.117.028303. Epub 2017 Apr 6.

  PMID: 28385948 BACKGROUND

• Zhou W, Bartlett DJ, Diehn FE, Glazebrook KN, Kotsenas AL, Carter RE, Fletcher JG, McCollough CH, Leng S. Reduction of Metal Artifacts and Improvement in Dose Efficiency Using Photon-Counting Detector Computed Tomography and Tin Filtration. Invest Radiol. 2019 Apr;54(4):204-211. doi: 10.1097/RLI.0000000000000535.

  PMID: 30562270 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hans Granfeldt, MD/PhD

  Region Östergötland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Granfeldt, MD/PhD

CONTACT

010-103 00 00; hans.granfeldt@regionostergotland.se

Linus Ohlsson, PhD-student

CONTACT

010-103 00 00; linus.ohlsson@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, cardiothoracic surgery (MD/PhD), deputy operational manager

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 2, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)