Characterization of Interventricular Conduction Measurements

Early Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Cardiac Resynchronization Therapy

• Registration Number: NCT01362465
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Study Start: 2011-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Resynchronization Therapy (CRT)	Cardiac Resynchronization Therapy	Implanting device to measure delays between paced chambers in heart failure patients.

Primary Outcome Measures

Name	Time	Method
Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.	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.