Attain StarFix™ Model 4195 Left Ventricular Lead

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00269230
• Collaborator: (none)
• Enrollment: 441
• Locations: 25
• Duration (Months): 12
• Patients Per Site: 17.6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Pacing Lead	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 441 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Attain StarFix™ Model 4195 Left Ventricular Lead
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. Safety and Efficacy at 3 months [3 Months]

Secondary Outcome Measures

1. Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study [Ongoing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Long Beach	California	United States
2		Palo Alto	California	United States
3		Newark	Delaware	United States
4		Jacksonville	Florida	United States
5		Orlando	Florida	United States
6		Atlanta	Georgia	United States
7		Lexington	Kentucky	United States
8		Grand Rapids	Michigan	United States
9		Saginaw	Michigan	United States
10		St. Paul	Minnesota	United States
11		St. Louis	Missouri	United States
12		Lincoln	Nebraska	United States
13		Newark	New Jersey	United States
14		Rochester	New York	United States
15		Durham	North Carolina	United States
16		Germantown	Tennessee	United States
17		Nashville	Tennessee	United States
18		Dallas	Texas	United States
19		Temple	Texas	United States
20		Milwaukee	Wisconsin	United States
21		Calgary	Alberta	Canada
22		Victoria	British Columbia	Canada
23		London	Ontario	Canada
24		Sainte-Foy	Quebec	Canada
25		Milano		Italy

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Stuart W Adler II, MD, St. Paul Heart Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00269230
• Other Study ID Numbers: 234
• First Posted: Dec 23, 2005
• Last Update Posted: Nov 20, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: cardiac resynchronization therapy, left ventricular Lead, Heart Failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Nov 20, 2008