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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QuickFlex Micro Model 1258T Left Heart Lead
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure, ICD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital-University of Alabama at Birmingham
  • Arkansas Cardiology
  • Arkansas Heart Hospital
  • Glendale Memorial Hospital and Medical Center
  • Regional Cardiology Associates
  • Midwest Heart Foundation
  • Central Baptist Hospital
  • St. John Hospital and Medical Center
  • Thoracic Cardiovascular Healthcare Foundation
  • Deborah Heart and Lung Center
  • St. Francis Hospital
  • EMH Regional Medical Center
  • St. Thomas Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QuickFlex micro 1258T left heart lead

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2008
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00763698
Brief Title
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
Official Title
QuickFlex Micro Model 1258T Left Heart Pacing Lead
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure, ICD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QuickFlex micro 1258T left heart lead
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
QuickFlex Micro Model 1258T Left Heart Lead
Other Intervention Name(s)
Model 1258T left heart pacing lead
Intervention Description
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
Primary Outcome Measure Information:
Title
Freedom From Left Ventricular Lead-related Complications
Description
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
Title
Percentage of Successful Left Ventricular Lead Implants
Description
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
Title
Left Ventricular Bipolar Pacing Capture Threshold (Volts)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Shipman
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital-University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arkansas Cardiology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Glendale Memorial Hospital and Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Thoracic Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
EMH Regional Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

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

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