Characterization of Interventricular Conduction Measurements (ICM)

September 18, 2012 updated by: Medtronic Cardiac Rhythm and Heart Failure
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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • TDSICM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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