Skip to main content
OpenTrials
Completed

NCT Number: NCT00763698

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital-University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuickFlex Micro Model 1258T Left Heart Lead

Device

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

Other names: Model 1258T left heart pacing lead

Primary outcomes

  1. Freedom From Left Ventricular Lead-related Complications

    Time frame: 3 months

    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.

  2. Percentage of Successful Left Ventricular Lead Implants

    Time frame: 3 months

    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.

  3. Left Ventricular Bipolar Pacing Capture Threshold (Volts)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

QuickFlex Micro Model 1258T Left Heart Pacing Lead

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 1, 2008
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.