NCT01293526

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Piedmont Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Control	Patients who respond will have leads will be placed using standard procedures.
DEVICE	Experimental	Patients who respond will have their leads placed based on study measurements.
DEVICE	Experimental 2	Patients who respond will have their leads placed based on standard lead placement.

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-02-10
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States