NCT00763698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 4, 2011

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

September 29, 2008

Results QC Date

July 26, 2011

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Keywords

Left heart pacing leadCardiac resynchronization therapy (CRT)Heart failureICD

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 months

Study Arms (1)

QuickFlex micro 1258T left heart lead

EXPERIMENTAL
Device: QuickFlex Micro Model 1258T Left Heart Lead

Interventions

QuickFlex Micro Model 1258T Left Heart LeadDEVICE

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

Also known as: Model 1258T left heart pacing lead
QuickFlex micro 1258T left heart lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Approved indication for CRT-D system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Hospital-University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91204, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Director, Clinical Affairs
Organization
St. Jude Medical
tshipman@sjm.com
(408) 522-6410

Study Officials

  • Tamara Shipman

    Abbott Medical Devices

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

May 1, 2010

Last Updated

February 19, 2019

Results First Posted

November 4, 2011

Record last verified: 2019-02

Locations

US(13)