Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01477658
Status:
UNKNOWN
Last Update Posted:
2013-05-07
First Post:
2011-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown.
Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.
Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.
Detailed Description:
This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB.
The design of the study will involve the following stages:
1. Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;
2. Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;
3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
4. Follow-up: patients will be monitored during 24 months.
The main end-points are:
* Clinical and functional changes (NYHA functional class)
* Heart failure hospitalization
* Quality of life
* Overall and cardiac mortality
* Cardiac resynchronization therapy and heart transplantation
The design of the study will involve the following stages:
1. Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;
2. Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;
3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
4. Follow-up: patients will be monitored during 24 months.
The main end-points are:
* Clinical and functional changes (NYHA functional class)
* Heart failure hospitalization
* Quality of life
* Overall and cardiac mortality
* Cardiac resynchronization therapy and heart transplantation
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: