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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293526
First Posted: February 10, 2011
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LivaNova
Information provided by (Responsible Party):
Piedmont Healthcare
  Purpose
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.

Condition Intervention
Heart Failure Device: Control Device: Experimental Device: Experimental 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Percent of responding patients [ Time Frame: 6 months ]
    Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.


Secondary Outcome Measures:
  • Comparison of echocardiography and SonR signals [ Time Frame: 6 months ]
    Correlation of the results of optimization performed by echocardiography with the optimal setting as defined by the SonR signal.


Enrollment: 39
Actual Study Start Date: February 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293526


Locations
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
LivaNova
Investigators
Principal Investigator: Dan Dan, MD Piedmont Heart Institute
  More Information

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT01293526     History of Changes
Other Study ID Numbers: SonR Access
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Piedmont Healthcare:
Heart failure
echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases