Clinical trial NCT01293526: Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR
Official title: Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
echocardiography
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2011-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Percent of responding patients
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of echocardiography and SonR signals
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
Study officials:
affiliation: Piedmont Heart Institute
name: Dan Dan, MD
role: PRINCIPAL_INVESTIGATOR
References: