NCT05449158

Brief Summary

Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

June 28, 2022

Last Update Submit

July 7, 2022

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation;atrioventricular node ablation;left bundle branch pacing

Outcome Measures

Primary Outcomes (1)

  • EF%

    aortic vestibular ejection fraction

    1-year

Secondary Outcomes (2)

  • cardiovascular all-cause mortality

    1week

  • Hospitalizations for heart failure

    1 years

Study Arms (2)

LAP Group

EXPERIMENTAL

Control of left atrial pressure changes by adjusting pacemaker frequency

Procedure: left atrial pressure regulation

Control Group

NO INTERVENTION

General pacemaker rate setting

Interventions

left atrial pressure regulationPROCEDURE

For patients after atrioventricular node ablation combined with left atrial appendage closure, the regulation of left atrial pressure can be controlled by adjusting the frequency of pacemaker.

LAP Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old atrial fibrillation patients

You may not qualify if:

  • There is a history of pacemaker implantation; patients after coronary artery bypass grafting; severe coronary stenosis or occlusion cannot be treated with reperfusion;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun Zhang

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yawei Xu, Ph.D

    Shanghai 10th People's Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 8, 2022

Study Start

January 1, 2021

Primary Completion

May 1, 2022

Study Completion

June 28, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After the research results are published；2 years；
Access Criteria
open
More information

Locations

CN(1)