Attain StarFix™ Model 4195 Left Ventricular Lead - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

November 18, 2008

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

Safety and Efficacy at 3 months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269230 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Attain StarFix™ Model 4195 Left Ventricular Lead

Official Title ^†

Attain StarFix™ Model 4195 Left Ventricular Lead

Brief Summary

People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator.

Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied.

The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Heart Failure

Intervention ^†

Device: Pacing Lead

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

441

Completion Date

July 2005

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

QRS > 130 ms (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) < 35% (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

Exclusion Criteria:

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada, Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269230

Responsible Party

CRDM Core Clinical, Medtronic CRDM

Secondary IDs ^††

Study Sponsor ^†

Medtronic Cardiac Rhythm Disease Management

Collaborators ^††

Investigators ^†

Principal Investigator:

Stuart W Adler II, MD

St. Paul Heart Clinic

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.