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

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yang Su
suyang-yiyi@163.com
+86 13817491747
Backup
Weilun Meng
mengweilun1996@qq.com
+86 18351999826
Time Frame
Start Date: 2022-11-01
Completion Date: 2025-04-01
Participants
Target number of participants: 100
Treatments
Active_comparator: His bundle pacing group
HBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. The HB capture threshold was accepted if lower than 3.0 V at 0.42ms.
Active_comparator: Left branch bundle pacing group
HBP was performed on the patient, and the detection of the His bundle potential during the procedure is the sign of the success of the procedure. During the procedure, the duration from the pacing signal to the peak of R wave (on V4-V6 lead) is measured as pacing to left ventricular activation time (p-LVAT). An eligible site of left bundle capture was confirmed if selective LBBP was demonstrated by ECG, if p-LVAT shortened abruptly \>10 ms through increasing pacing output, or if p-LVAT stayed shortest and stable at the site.
Active_comparator: Right ventricular pacing group
If we could not achieve an acceptable HB or LBB capture after five attempts of lead positioning or a fluoroscopy exposure time over 30min, the lead was then placed in the RV with traditional approach.
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov