Study Stopped
PI left institution, no replacement
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR
SonR Access
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2011
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 18, 2024
December 1, 2024
3.3 years
February 9, 2011
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
Comparison of echocardiography and SonR signals
6 months
Study Arms (3)
Experimental 1
EXPERIMENTALPatients who respond will have their leads placed based on study measurements.
Control
EXPERIMENTALLeads will be placed using standard procedures.
Experimental 2
EXPERIMENTALPatients who respond will have their leads placed based on standard lead placement.
Interventions
Patients who respond will have their leads placed based on study measurements.
Patients who respond will have their leads placed based on standard lead placement.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piedmont Healthcarelead
- LivaNovacollaborator
Study Sites (1)
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Dan, MD
Piedmont Heart Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
February 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 18, 2024
Record last verified: 2024-12