Back to resultsThe Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation (LAP-TOP)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
left atrial pressure regulation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation;, atrioventricular node ablation;, left bundle branch pacing
Eligibility Criteria
Inclusion Criteria:
18-85 years old atrial fibrillation patients
Exclusion Criteria:
There is a history of pacemaker implantation; patients after coronary artery bypass grafting; severe coronary stenosis or occlusion cannot be treated with reperfusion;
Sites / Locations
- Jun Zhang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LAP Group
Control Group
Arm Description
Control of left atrial pressure changes by adjusting pacemaker frequency
General pacemaker rate setting
Outcomes
Primary Outcome Measures
EF%
aortic vestibular ejection fraction
Secondary Outcome Measures
cardiovascular all-cause mortality
Proportion of patients dying from cardiovascular causes
Hospitalizations for heart failure
Hospitalizations for heart failure
Full Information
NCT ID
NCT05449158
First Posted
June 28, 2022
Last Updated
July 7, 2022
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05449158
Brief Title
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation
Acronym
LAP-TOP
Official Title
Effects of Left Atrial Pressure-guided Ventricular Rate Regulation on Cardiac Function in Patients Therapy With Atrioventricular Node Ablation Combined With Left Bundle Branch Pacing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing
Detailed Description
Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing. For patients with non-valvular atrial fibrillation who received atrioventricular node ablation combined with left bundle branch pacing in our hospital, a left atrial pressure catheter was used to monitor atrial pressure during the operation, and a lower average atrial pressure was obtained by adjusting the pacing frequency of the pacemaker. In a randomized controlled manner, the postoperative echocardiography, cardiothoracic ratio, cardiac function, etc. were compared between patients without atrial pressure monitoring and those who received atrial pressure adjustment, in order to clarify the effect of left atrial pressure-guided ventricular rate adjustment on atrioventricular node ablation combined with left bundle Benefit of pacing patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation;, atrioventricular node ablation;, left bundle branch pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAP Group
Arm Type
Experimental
Arm Description
Control of left atrial pressure changes by adjusting pacemaker frequency
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
General pacemaker rate setting
Intervention Type
Procedure
Intervention Name(s)
left atrial pressure regulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
EF%
Description
aortic vestibular ejection fraction
Time Frame
1-year
Secondary Outcome Measure Information:
Title
cardiovascular all-cause mortality
Description
Proportion of patients dying from cardiovascular causes
Time Frame
1week
Title
Hospitalizations for heart failure
Description
Hospitalizations for heart failure
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-85 years old atrial fibrillation patients
Exclusion Criteria:
There is a history of pacemaker implantation; patients after coronary artery bypass grafting; severe coronary stenosis or occlusion cannot be treated with reperfusion;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yawei Xu, Ph.D
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jun Zhang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After the research results are published；2 years；
IPD Sharing Access Criteria
open
IPD Sharing URL
http://www.chictr.org.cn/index.aspx
Learn more about this trial
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation
We'll reach out to this number within 24 hrs