Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05575557
Status:
RECRUITING
Last Update Posted:
2022-12-29
First Post:
2022-09-17
Brief Title:
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
Sponsor:
Shanghai 10th Peoples Hospital
Organization:
Shanghai 10th Peoples Hospital
Study Overview
Official Title:
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 EF35 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 proximaldistal 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
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 EF35 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 proximaldistal 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None