- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05449158
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation (LAP-TOP)
July 7, 2022 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital
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
Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200072
- Jun Zhang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LAP Group
Control of left atrial pressure changes by adjusting pacemaker frequency
|
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.
|
No Intervention: Control Group
General pacemaker rate setting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EF%
Time Frame: 1-year
|
aortic vestibular ejection fraction
|
1-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiovascular all-cause mortality
Time Frame: 1week
|
Proportion of patients dying from cardiovascular causes
|
1week
|
Hospitalizations for heart failure
Time Frame: 1 years
|
Hospitalizations for heart failure
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yawei Xu, Ph.D, Shanghai 10th People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
June 28, 2022
Study Registration Dates
First Submitted
June 28, 2022
First Submitted That Met QC Criteria
July 7, 2022
First Posted (Actual)
July 8, 2022
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAP-TOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
After the research results are published;2 years;
IPD Sharing Access Criteria
open
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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