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

NCT05575557 | Unknown

• 1 other identifier: PROPHET
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

physiological pacing; right heart; hemodynamics examination; acute and chronic impact

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Changes in systolic, diastolic and mean pulmonary artery pressure by Swan-Ganz catheter from pre-procedure level

  5 minutes after ventricular pacing lead implantation

• Changes in systolic, diastolic and mean right ventricular pressure by Swan-Ganz catheter from pre-procedure level

  5 minutes after ventricular pacing lead implantation

• Changes in systolic, diastolic and mean right atrial pressure by Swan-Ganz catheter from pre-procedure level

  5 minutes after ventricular pacing lead implantation

• Changes in right ventricular global longitudinal strain rate from pre-porcedure level

  24 hours post procedure, 1st month, 3rd month, 12th month since procedure

• Changes in tricuspid annular plane systolic excursion from pre-procedure level

  24 hours post procedure, 1st month, 3rd month, 12th month since procedure

Study Arms (3)

His bundle pacing group

ACTIVE COMPARATOR

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.

Procedure: Right heart catheterization

Left branch bundle pacing group

ACTIVE COMPARATOR

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.

Procedure: Right heart catheterization

Right ventricular pacing group

ACTIVE COMPARATOR

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.

Procedure: Right heart catheterization

Interventions

Right heart catheterization PROCEDURE

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.

His bundle pacing group; Left branch bundle pacing group; Right ventricular pacing group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Sick Sinus Syndrome; Atrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Study Officials

• Yawei Xu

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Su

CONTACT

+86 13817491747; suyang-yiyi@163.com

Weilun Meng

CONTACT

+86 18351999826; mengweilun1996@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: October 12, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 29, 2022

Record last verified: 2022-10

Locations

CN (1)