Characterization of Interventricular Conduction Measurements (ICM)

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Cardiac Resynchronization Therapy

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.	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.	30 minutes

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): September 20, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TDSICM