We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization of Interventricular Conduction Measurements (ICM)

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.
 
ClinicalTrials.gov Identifier: NCT01362465
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 20, 2012
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Cardiac Resynchronization Therapy Early Phase 1

Detailed Description:
The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Interventricular Conduction Measurements
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cardiac Resynchronization Therapy (CRT)
Implanting device to measure delays between paced chambers in heart failure patients.
 Procedure: Cardiac Resynchronization Therapy
Implanting device to measure delays between paced chambers in heart failure patients.
Other Name: CRT


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system. [ Time Frame: 30 minutes ]
    This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is greater than 18 years of age.
  • The patient or the patient's legally authorized representative is willing to give informed consent.
  • CRT indicated guidelines.
  • Patient is receiving a Medtronic IPG or ICD.

Exclusion Criteria:

  • Patients who are pregnant.
  • Patient is in AF.
  • Patient with 3rd degree AV block.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01362465


Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Brett Atwater, MD Durham VA
Principal Investigator: Robert Hoyt, MD Catholic Health Initiative Iowa Corp
Principal Investigator: Eric E Johnson, MD Sterns Cardiovascular Foundation
Principal Investigator: John F Beshai, MD University of Chicago
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01362465    
Other Study ID Numbers: TDSICM
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases