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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Experimental; Device: Control; Device: Experimental 2

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1; Patients who respond will have their leads placed based on study measurements.	Device: Experimental; Patients who respond will have their leads placed based on study measurements.
Experimental: Control; Leads will be placed using standard procedures.	Device: Control; Patients who respond will have leads will be placed using standard procedures.
Experimental: Experimental 2; Patients who respond will have their leads placed based on standard lead placement.	Device: Experimental 2; Patients who respond will have their leads placed based on standard lead placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Piedmont Healthcare
• Collaborators: LivaNova
• Investigators: Principal Investigator: Dan Dan, MD, Piedmont Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SonR Access