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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Right heart catheterization
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring physiological pacing, right heart, hemodynamics examination, acute and chronic impact

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Tenth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

His bundle pacing group

Left branch bundle pacing group

Right ventricular pacing group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events after procedure
rehospitalization due to acute heart failure, all-cause mortality, cardiac death

Secondary Outcome Measures

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
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
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
Changes in right ventricular global longitudinal strain rate from pre-porcedure level
Right ventricular global longitudinal strain rate measured at four-chamber view
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
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
Changes in pulmonary artery systolic pressure by echocardiography from pre-procedure level
Pulmonary artery systolic pressure was approximated by echocardiography measuring tricuspid regurgitation pressure
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
Change from baseline general quality of life evaluation
Change in EQ-5D-5L questionnaire score
Change from baseline heart failure-specific quality of life evaluation
Change in Kansas City Cardiomyopathy Questionnaire score
Change in heart failure biomarker from baseline
Change in level of blood brain natriuretic peptide
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

Full Information

First Posted
September 17, 2022
Last Updated
December 24, 2022
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05575557
Brief Title
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
Official Title
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Su
Phone
+86 13817491747
Email
suyang-yiyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weilun Meng
Phone
+86 18351999826
Email
mengweilun1996@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yawei Xu
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yawei Xu
Phone
+86 18917683030
Email
xuyawei@tongji.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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