Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575557
• Other study ID #: PROPHET
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2022
• Source: Shanghai 10th People's Hospital
• Contact: Yang Su
• Phone: +86 13817491747
• Email: suyang-yiyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP.

At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.

Description:

This study was designed to investigate the acute and chronic effect of different pacing methods on the function of pulmonary artery and right heart.

Studied population: The investigated population are patients eligible for pacemaker implantation and cardiac resynchronization therapy and specified as followed:

1. age over 18; 2. persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation; 3. heart failure patients with EF≤35% and complete left bundle branch block; 4. patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation.

Investigated procedure: Physiological pacing as the principal studied procedure is defined as pacing with ventricular lead implanted at proximal/distal His bundle or left bundle branch. While right ventricular pacing was defined as conventional pacing with ventricular lead implanted at right ventricular apex.

Importantly, Swan-Ganz catheter was performed before and after physiological pacing. By the internal jugular vein before the pacemaker implantation procedure. After the measurement, the catheter was indwelled and measurement was taken. Thereafter, pacemaker implantation procedure was followed. After completing electrode fixation and continuous ventricular pacing for at least 5 minutes, ensuring ventricular pacing ratio > 80%, the SW catheter measurement was performed again to acquire indices under physiological pacing.

Follow up: The study is designed to have scheduled follow-up at 1 month, 3-month, 6-month and 12 months after procedure. Primary endpoint is a composite endpoint of all-cause mortality and HF rehospitalization. And other imageological measurement (echocardiography) biochemical test (blood BNP) and functional evaluation (6MWT) were performed to appraise the impact of physiological pacing on the condition of the participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• age over 18

• persistent atrial fibrillation patients with uncontrolled heart rate requiring atrioventricular node ablation

• patients with sick sinus syndrome or atrioventricular block eligible for pacemaker implantation

• patients who can understand and sign informed consent

Exclusion Criteria:

• age below 18 or over 99

• concomitant diseases that may affect right heart function, including COPD, pulmonary infection, history of pulmonary embolism or right myocardial infarction, myocarditis, systemic disease

• patients with temporary pacemaker implanted

• right heart catheterization contraindications, including acute infection and embolic events

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Atrioventricular Block
• Heart Failure With Reduced Ejection Fraction
• Sick Sinus Syndrome

Intervention

Procedure:
• Right heart catheterization
All groups were detected with SW catheter by the internal jugular vein before the procedure. After the measurement, the catheter was indwelled, and the pacemaker implantation procedure was started. After ventricular pacing for 5 minutes, the SW catheter measurement was performed again. After the measurement, the SW catheter was withdrawn.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events after procedure	rehospitalization due to acute heart failure, all-cause mortality, cardiac death	From date of inclusion until the date of documented adverse events, assessed up to 1 year
Secondary	Changes in systolic, diastolic and mean pulmonary artery pressure by Swan-Ganz catheter from pre-procedure level	Measurement of systolic, diastolic and pulmonary artery pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation	5 minutes after ventricular pacing lead implantation
Secondary	Changes in systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter from pre-procedure level	Measurement of systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation	5 minutes after ventricular pacing lead implantation
Secondary	Changes in systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter from pre-procedure level	Measurement of systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter before and 5 minutes after ventricular pacing lead implantation	5 minutes after ventricular pacing lead implantation
Secondary	Changes in right ventricular global longitudinal strain rate from pre-porcedure level	Right ventricular global longitudinal strain rate measured at four-chamber view	24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Secondary	Changes in tricuspid annular plane systolic excursion from pre-procedure level	Tricuspid annular plane systolic excursion by tissue doppler imaging measured at four-chamber view	24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Secondary	Changes in Tei index from pre-procedure level	Tei index calculated from measurement by tissue doppler imaging of tricuspid moving velocity at four-chamber view	24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Secondary	Changes in pulmonary artery systolic pressure by echocardiography from pre-procedure level	Pulmonary artery systolic pressure was approximated by echocardiography measuring tricuspid regurgitation pressure	24 hours post procedure, 1st month, 3rd month, 12th month since procedure
Secondary	Change from baseline walking distance of 6-min walk test between different groups at 6 month after procedure	Maximum walking distance measured from 6-min walk test	1st month, 3rd month, 12th month since procedure
Secondary	Change from baseline general quality of life evaluation	Change in EQ-5D-5L questionnaire score	1st month, 3rd month, 12th month since procedure
Secondary	Change from baseline heart failure-specific quality of life evaluation	Change in Kansas City Cardiomyopathy Questionnaire score	1st month, 3rd month, 12th month since procedure
Secondary	Change in heart failure biomarker from baseline	Change in level of blood brain natriuretic peptide	1st month, 3rd month, 12th month since procedure
Secondary	Changes in blood pressure from baseline between different groups at 6 months after procedure	Change of systolic and diastolic blood pressure, an average value of three times	1st month, 3rd month, 12th month since procedure