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3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy

Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02426203
Enrollment
51
Registered
2015-04-24
Start date
2015-05-31
Completion date
2016-06-30
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Echocardiography

Brief summary

Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.

Interventions

Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.

Sponsors

Papworth Hospital NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients * undergoing pulmonary endarterectomy surgery at Papworth Hospital * Willing to provide informed consent

Exclusion criteria

* Patient refusal * Contraindication to transoesophageal echocardiography * Technical difficulty preventing adequate echocardiographic assessment of right heart function

Design outcomes

Primary

MeasureTime frameDescription
Right ventricular ejection fraction6 months3-dimensional acquisition of right ventricular ejection fraction using echocardiography

Secondary

MeasureTime frame
Tricuspid annular plane systolic excursion6 months
Right ventricular fractional area change6 months
Right ventricular strain6 months
Pulmonary artery acceleration time6 months
Left ventricular ejection fraction6 months

Contacts

Primary ContactJames E Moore, FANZCA FCICM
james.moore10@nhs.net44 1480 830 541
Backup ContactAndrew A Klein, FRCA FFICM
andrew.klein@nhs.net44 1480 830 541

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026