Effects of Chronic Right Ventricular Pacing in Children W... | NCT01477658

Studies
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

NCT01477658

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

May 7, 2013Estimated

Enrollment

140Actual

Phase

Not provided

Conditions

Congenital Complete Atrioventricular Heart Block
High Grade Atrioventricular Block
Postoperative Complete Heart Block

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2013Estimated

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 21, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2013

Last Update Posted Date

May 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roberto Costa, Associated Professor of Cardiovascular Surgery, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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;
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;
Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
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

Conditions Module

Conditions

Congenital Complete Atrioventricular Heart Block
High Grade Atrioventricular Block
Postoperative Complete Heart Block

Keywords

Congenital Complete Atrioventricular Heart Block
Pacemaker
Cardiac pacing
Children
Heart failure
Ventricular dyssynchrony
Echocardiography
Quality of life
Six-minute walk test
Young adults

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Congenital AV Block		Patients diagnosed with Congenital Complete Atrioventricular Heart Block
Postoperative AV Block		Patients diagnosed with postoperative AV block

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		24 months after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Echocardiogram and Clinical Composite		baseline and 24 months after enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age <18 years at initial pacemaker implantation
Advanced AV block with /without congenital heart defects
Time under cardiac pacing superior than one year
Unicameral or atrioventricular pacing in single right ventricle site
Informed consent of the patient or responsible

Exclusion Criteria:

Bifocal or biventricular pacing
Discontinuing use of the device for recovery of atrioventricular conduction
Cardiac transplantation
Inability to participate in the study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Ambulatory Care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto Costa, MD, PhD	University of Sao Paulo	Study Chair
Roberto M Oliveira Jr, MD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Institute (InCor) of University of São Paulo Medical School (Brazil)		São Paulo	São Paulo	05403000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
C535758	Congenital heart block
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided