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CTRI Number  CTRI/2025/12/099277 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Observing right side heart function in adults with left valvular heart disease undergoing heart surgery 
Scientific Title of Study   Pulmonary pulse transit time in predicting right ventricular-pulmonary artery uncoupling in adults with left valvular heart disease undergoing cardiac surgery: A prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  devishree das 
Designation  Assistant Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8895299296  
Fax    
Email  devishreedas111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  devishree das 
Designation  Assistant Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar


ORISSA
751019
India 
Phone  8895299296  
Fax    
Email  devishreedas111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  devishree das 
Designation  Assistant Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8895299296  
Fax    
Email  devishreedas111@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS, Bhubaneswar 
Address  Sijua, Patrapada, Bhubaneswar, Khorda, Orissa, 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Devishree Das  AIIMS, Bhubaneswar  Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khorda
Khordha
ORISSA 
8895299296

devishreedas111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committeeee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (2) ICD-10 Condition: I050||Rheumatic mitral stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  adult patients with left valvular heart disease and moderate to severe TR undergoing elective cardiac surgery will be included 
 
ExclusionCriteria 
Details  Patients with underlying structural heart disease such as atrial septal defects, congenital heart disease, and insufficient transesophageal echocardiography (TEE) image quality will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
correlation of pPTT with a validated predictive parameter of RV-PA uncoupling  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
correlation of pPTT with other parameters of RV-PA uncoupling such as TAPSE/PASP, S’/RVSP, RV-FAC/RVSP, RV-EF/PASP, RV LS/RVSP   before surgery 
Difference in pPTT between coupled and uncoupled RVs  before surgery 
Cutoff values of pPTT and normalize pPTT that predicts RV-PA uncoupling  before surgery 
Determine the correlation of pPTT with normalize pPTT  before surgery 
Incidence of in hospital POAF and cutoff value of pPTT for POAF  before surgery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pulmonary pulse transit time (pPTT) is a novel non-invasive echocardiographic measure to assess pulmonary arterial hemodynamic. It is the time needed for the pulse wave to propagate from the right ventricular outflow tract (RVOT) to the left atrium. Pulse wave velocity (PWV) defined as the velocity of pressure waves traveling through the arterial system, correlates inversely with arterial compliance in the circulation.  With decreasing compliance, pulse wave velocity increases, and the time taken by the pressure wave to travel between 2 vascular points shortens. pPTT has been identified as clinically important surrogates for assessing arterial compliance in the pulmonary circulation but there is technical difficulties in measuring pulse wave velocity in the pulmonary circulation. Recently, Wibmer et al. defined pPTT, as the delay between onset of ventricular electrical activity (on electrocardiogram) and the arrival of the pulse wave in the pulmonary vein (as determined by Doppler echocardiography of the pulmonary vein), and found to be reduced in patients with pulmonary hypertension.  Wibmer et al. postulated that pPTT was shortened because of decreased pulmonary artery(PA) compliance and increased pulse wave velocity, and they proposed pPTT as a potential index of PA compliance.  pPTT has been studied in chronic obstructive pulmonary disease and connective tissue disorder induce pulmonary hypertension i.e precapillary hypertension. However, Gurbuz et al, demonstrated prolonged pPTT in patients with significant mitral stenosis i.e postcapillary hypertension. They found a positive correlation between pPTT with pulmonary artery systolic pressure(PASP) and inverse correlation with tricuspid annular plane systolic excursion(TAPSE) which were the predictors of increased right ventricle(RV) afterload. Also, pPTT directly related to left atrial volume index(LAVi) which is a predictor of postoperative atrial fibrillation(POAF). Both RV-PV coupling and POAF were not discussed in this study. In addition, no other study has explored the usefulness of pPTT in predicting the RV-PA uncoupling and POAF which are commonly seen in patients with left heart disease.

Therefore, the primary aim of the study is to further characterisation of pPTT in patients with left heart disease and to evaluate whether it predicts RV-PA uncoupling and POAF in this cohort of patients. 

 
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