Attain StarFix™ Model 4195 Left Ventricular Lead

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00269230
First received: December 21, 2005
Last updated: November 18, 2008
Last verified: October 2008
  Purpose

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 Intervention
Heart Failure
Device: Pacing Lead

Medtronic Cardiac Rhythm Disease Management has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Attain StarFix™ Model 4195 Left Ventricular Lead

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

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 ]

Enrollment: 441
Study Start Date: July 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pacing Lead
    Left ventricular pacing lead
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269230

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Stuart W Adler II, MD St. Paul Heart Clinic
  More Information

No publications provided

Responsible Party: CRDM Core Clinical, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00269230     History of Changes
Other Study ID Numbers: 234
Study First Received: December 21, 2005
Last Updated: November 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
cardiac resynchronization therapy, left ventricular Lead, Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014