AV Block Clinical Trial
Official title:
Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial
NCT number | NCT03556189 |
Other study ID # | AV delay |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | December 2019 |
This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. The investigators designed to randomize AV block patients who already have or anticipated to receive pacemaker, into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. The primary endpoint is improvement of LV systolic function and the secondary endpoint is change in left ventricular volume, cardiac output, BNP, 6-minute walk capacity and NYHA class after one year.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Received or scheduled to receive permanent pacemaker due to AV block Exclusion Criteria: - Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (=mild) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul St Mary's Hospital | Seoul | Seo Ch-gu |
Lead Sponsor | Collaborator |
---|---|
Yong Seog Oh |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular ejection fraction | one year after randomization | ||
Secondary | Left ventricular end-diastolic diameter | one year after randomization | ||
Secondary | Left ventricular end-systolic diameter | one year after randomization | ||
Secondary | cardiac output | one year after randomization | ||
Secondary | BNP | one year after randomization | ||
Secondary | 6-minute walking test | one year after randomization | ||
Secondary | NYHA class | one year after randomization |
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