Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR (SonR Access)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Experimental
Experimental 2
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, echocardiography
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
Sites / Locations
- Piedmont Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Experimental 1
Control
Experimental 2
Arm Description
Patients who respond will have their leads placed based on study measurements.
Leads will be placed using standard procedures.
Patients who respond will have their leads placed based on standard lead placement.
Outcomes
Primary Outcome Measures
Percent of responding patients
Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01293526
First Posted
February 9, 2011
Last Updated
November 16, 2017
Sponsor
Piedmont Healthcare
Collaborators
LivaNova
1. Study Identification
Unique Protocol Identification Number
NCT01293526
Brief Title
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR
Acronym
SonR Access
Official Title
Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Piedmont Healthcare
Collaborators
LivaNova
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
OR
Group 3: Standard lead placement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, echocardiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
Patients who respond will have their leads placed based on study measurements.
Arm Title
Control
Arm Type
Experimental
Arm Description
Leads will be placed using standard procedures.
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Patients who respond will have their leads placed based on standard lead placement.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Patients who respond will have leads will be placed using standard procedures.
Intervention Type
Device
Intervention Name(s)
Experimental
Intervention Description
Patients who respond will have their leads placed based on study measurements.
Intervention Type
Device
Intervention Name(s)
Experimental 2
Intervention Description
Patients who respond will have their leads placed based on standard lead placement.
Primary Outcome Measure Information:
Title
Percent of responding patients
Description
Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of echocardiography and SonR signals
Description
Correlation of the results of optimization performed by echocardiography with the optimal setting as defined by the SonR signal.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Dan, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR
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