Reverse Electrical Remodeling of Native Conduction in Car... | NCT01924221

Studies
Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

NCT01924221

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Aug 30, 2022Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Heart Failure
Patients Undergoing CRT-D Device Implantation

Interventions

Not provided

Countries

United States

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Aug 14, 2013

First Submission Date that Met QC Criteria

Aug 14, 2013

First Posted Date

Aug 16, 2013Estimated

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

Aug 29, 2022

Last Update Posted Date

Aug 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
CRT		Patients with implanted cardiac resynchronization therapy defibrillator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between electrical and mechanical remodeling	correlation between electrical and mechanical measures of dyssynchrony	6 months after CRT implantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing implantation of a CRT-D

Exclusion Criteria:

age < 18 y
pregnancy or planned pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Heart Failure Patients undergoing implantation of cardiac resynchronization therapy defibrillator

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Larisa Tereshchenko, MD, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided