Characterization of Interventricular Conduction Measurements (ICM)

Medtronic

Status and phase: Completed; Early Phase 1

Conditions: Heart Failure

Treatments: Procedure: Cardiac Resynchronization Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362465

TDSICM

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cardiac Resynchronization Therapy (CRT)

Experimental group

Description:

Implanting device to measure delays between paced chambers in heart failure patients.

Treatment:

Procedure: Cardiac Resynchronization Therapy