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Characterization of Interventricular Conduction Measurements (ICM)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01362465
First received: May 25, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes

May 25, 2011
September 18, 2012
June 2011
April 2012   (final data collection date for primary outcome measure)
Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01362465 on ClinicalTrials.gov Archive Site
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Characterization of Interventricular Conduction Measurements
Characterization of Interventricular Conduction Measurements

This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

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.
Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure
Procedure: Cardiac Resynchronization Therapy
Implanting device to measure delays between paced chambers in heart failure patients.
Other Name: CRT
Experimental: Cardiac Resynchronization Therapy (CRT)
Implanting device to measure delays between paced chambers in heart failure patients.
Intervention: Procedure: Cardiac Resynchronization Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01362465
TDSICM
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Medtronic
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
Medtronic Cardiac Rhythm Disease Management
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP