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Clinical Trials/NCT02426203
NCT02426203
Unknown
Not Applicable

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

Papworth Hospital NHS Foundation Trust0 sites51 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Thromboembolic Pulmonary Hypertension
Sponsor
Papworth Hospital NHS Foundation Trust
Enrollment
51
Primary Endpoint
Right ventricular ejection fraction
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
June 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Right ventricular ejection fraction

Time Frame: 6 months

3-dimensional acquisition of right ventricular ejection fraction using echocardiography

Secondary Outcomes

  • Right ventricular fractional area change(6 months)
  • Tricuspid annular plane systolic excursion(6 months)
  • Right ventricular strain(6 months)
  • Left ventricular ejection fraction(6 months)
  • Pulmonary artery acceleration time(6 months)

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