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

Piedmont Healthcare

Status: Withdrawn

Conditions: Heart Failure

Treatments: Device: Experimental 2; Device: Experimental; Device: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01293526

SonR Access

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Experimental 1

Experimental group

Description:

Patients who respond will have their leads placed based on study measurements.

Treatment:

Device: Experimental

Control

Experimental group

Description:

Leads will be placed using standard procedures.

Treatment:

Device: Control

Experimental 2

Experimental group

Description:

Patients who respond will have their leads placed based on standard lead placement.

Treatment:

Device: Experimental 2