Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

Abbott Medical Devices86 enrolled

Overview

This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device. Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

QuickFlex Micro Model 1258T Left Heart LeadDEVICE

Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Approved indication for CRT-D system Exclusion Criteria: * Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment * Previous left ventricular (LV) lead implant * Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment

Locations (13)

University Hospital-University of Alabama at Birmingham

Birmingham, Alabama, United States

Arkansas Cardiology

Little Rock, Arkansas, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Freedom From Left Ventricular Lead-related Complications

A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.

Time frame: 3 months

Percentage of Successful Left Ventricular Lead Implants

Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.

Time frame: 3 months

Left Ventricular Bipolar Pacing Capture Threshold (Volts)

The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of \< 3 volts is required to meet this endpoint.

Time frame: 3 months

Data from ClinicalTrials.gov

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