Acute Optimization of Cardiac Resynchronization Therapy (... | NCT01293526

Studies
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR

NCT01293526

Sponsor

Piedmont Healthcare

Status

Withdrawn

Last Update Posted

Dec 18, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Control
Experimental
Experimental 2

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left institution, no replacement

Expanded Access Info

Start Date

Feb 2011Actual

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 10, 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

Dec 13, 2024

Last Update Posted Date

Dec 18, 2024Actual

Name	Class
LivaNova	INDUSTRY

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

The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

Detailed Description

A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.

Group 1: Patients with no response

Patients with a successful response will be randomized to:

Group 2: Lead placement based on study measurements

Group 3: Standard lead placement

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental 1	Experimental	Patients who respond will have their leads placed based on study measurements.	Device: Experimental
Control	Experimental	Leads will be placed using standard procedures.	Device: Control
Experimental 2	Experimental	Patients who respond will have their leads placed based on standard lead placement.	Device: Experimental 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Device	Patients who respond will have leads will be placed using standard procedures.	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of responding patients	Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Comparison of echocardiography and SonR signals	Correlation of the results of optimization performed by echocardiography with the optimal setting as defined by the SonR signal.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
Indicated for CRT according to current guidelines
QRS Duration between 120 ms and 150 ms
Able and willing to provide consent and Authorization of Use of PHI

Exclusion Criteria:

Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
Planned, or recent heart surgery or revascularization within the last three months
Already enrolled in other study that precludes enrollment in this study per Principal Investigator
Known Pregnancy at the time of enrollment
Age less than 18 at the time of enrollment
Unable to comply with follow-up requirements
Chronic Atrial Fibrillation
Recent history of medical non-compliance as determined by the investigator
Unable or unwilling to provide consent and Authorization of Use of PHI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Dan, MD	Piedmont Heart Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Piedmont Heart Institute		Atlanta	Georgia	30309	United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases