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Recruiting NCT05376254

3D Assessment of RV Function in Patients Undergoing LVAD Implantation

— Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation

Overview

This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.

Detailed description

There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).

Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.

Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Primary outcome measures

  • Left ventricular strain [Time frame: 24 hours]
  • Right ventricular fractional area of change [Time frame: 24 hours]
  • Right ventricular free wall strain [Time frame: 24 hours]
  • Right ventricular end diastolic volume [Time frame: 24 hours]
  • Light ventricular end diastolic volume [Time frame: 24 hours]
  • Right ventricular end systolic volume [Time frame: 24 hours]
  • Left ventricular end systolic volume [Time frame: 24 hours]
  • Right ventricular ejection fraction [Time frame: 24 hours]
  • Left ventricular ejection fraction [Time frame: 24 hours]
  • Tricuspid annular plane systolic excursion [Time frame: 24 hours]
Secondary outcome measures (11)
  • Age [Time frame: 1 day]
  • Gender [Time frame: 1 day]
  • Body Surface Area [Time frame: 1 day]
  • Central venous pressure [Time frame: 14 days]
  • Pulmonary artery pulsatility index [Time frame: 14 days]
  • Need for right ventricular mechanical support [Time frame: 14 days]
  • Need for pulmonary vasodilators [Time frame: 14 days]
  • Need for vasopressors [Time frame: 14 days]
  • Aspartate aminotransferase [Time frame: 14 days]
  • Bilirubin [Time frame: 14 days]
  • Creatinine [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

  • Patients will be eligible to be included in the study if they receive either a left-sided:
  • HeartMate III (Thoratec, Pleasanton, CA)
  • HeartWare HVAD (HeartWare, Oakville CA)
  • Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.

Exclusion criteria

  • Patients will be excluded if::
  • hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
  • additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
  • sternal closure at the end of the procedure is not possible
  • RV mechanical support was introduced concurrently with LVAD implantation
  • inadequate image quality required to obtain a 3D protocol
  • known contraindication to TEE
  • unexpected inability to advance probe into the mid-esophagus

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Mazankowski Alberta Heart Institute — Edmonton

Publications

  • Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9. PMID 33559474
  • Amzulescu MS, De Craene M, Langet H, Pasquet A, Vancraeynest D, Pouleur AC, Vanoverschelde JL, Gerber BL. Myocardial strain imaging: review of general principles, validation, and sources of discrepancies. Eur Heart J Cardiovasc Imaging. 2019 Jun 1;20(6):605-619. doi: 10.1093/ehjci/jez041. PMID 30903139
  • Friedberg MK, Redington AN. Right versus left ventricular failure: differences, similarities, and interactions. Circulation. 2014 Mar 4;129(9):1033-44. doi: 10.1161/CIRCULATIONAHA.113.001375. No abstract available. PMID 24589696
  • Amsallem M, Mercier O, Kobayashi Y, Moneghetti K, Haddad F. Forgotten No More: A Focused Update on the Right Ventricle in Cardiovascular Disease. JACC Heart Fail. 2018 Nov;6(11):891-903. doi: 10.1016/j.jchf.2018.05.022. Epub 2018 Oct 10. PMID 30316939
  • Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Associati PMID 29650544
  • Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, PMID 20643330
  • Magunia H, Dietrich C, Langer HF, Schibilsky D, Schlensak C, Rosenberger P, Nowak-Machen M. 3D echocardiography derived right ventricular function is associated with right ventricular failure and mid-term survival after left ventricular assist device implantation. Int J Cardiol. 2018 Dec 1;272:348-355. doi: 10.1016/j.ijcard.2018.06.026. Epub 2018 Jun 8. PMID 29903518
  • Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available. PMID 18378625

Identifiers

NCT: NCT05376254 · Pro00112239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗