NCT00271544

Brief Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Feb 2007

Geographic Reach
2 countries

24 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

December 28, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 2, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 25, 2009

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

December 28, 2005

Results QC Date

April 30, 2009

Last Update Submit

September 24, 2009

Conditions

Heart Failure

Keywords

heart failurecardiac pacingleft ventricular leadcardiac resynchronization therapy

Outcome Measures

Primary Outcomes (3)

  • Safety (Subjects Without a Model 4196 Lead Related Complication)

    A subject who was free of a Model 4196 lead related complication by one month visit.

    One Month

  • Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)

    Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

    One Month

  • Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)

    Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

    Three Months

Secondary Outcomes (16)

  • Subjects Successfully Implanted With Model 4196 Lead

    Implant

  • Subjects Successfully Implanted After Cannulation

    Implant

  • All Left Ventricular Leads

    Implant

  • All Medtronic Left Ventricular Leads (Attain Family)

    Implant

  • Cannulation Time

    Implant

  • +11 more secondary outcomes

Study Arms (1)

4196 Lead

EXPERIMENTAL

Non-randomized study.

Device: Pacing Lead

Interventions

Pacing LeadDEVICE

implant and follow-up of study device

4196 Lead

Eligibility Criteria

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

You may qualify if:

  • QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
  • Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
  • Subject has moderate to severe heart failure despite medications

You may not qualify if:

  • Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
  • Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
  • Subjects that have had certain surgeries on their heart within the past three months
  • Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Anchorage, Alaska, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Palo Alto, California, United States

Location

Unknown Facility

Davenport, Iowa, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baton Rouge, Louisiana, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Mayfield Heights, Ohio, United States

Location

Unknown Facility

Wynnewood, Pennsylvania, United States

Location

Unknown Facility

Spartanburg, South Carolina, United States

Location

Unknown Facility

Kingsport, Tennessee, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Hang Nguyen
Organization
Medtronic CRDM Clinical Research
hang.t.nguyen@medtronic.com
800-328-2518

Study Officials

  • Brian Ramza, MD, PHD

    St. Luke's Mid America Heart Institute, Kansas City MO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
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

Study Record Dates

First Submitted

December 28, 2005

First Posted

January 2, 2006

Study Start

February 1, 2007

Primary Completion

August 1, 2007

Study Completion

December 1, 2008

Last Updated

September 28, 2009

Results First Posted

August 25, 2009

Record last verified: 2009-09

Locations

US(19)CA(5)