Heart FailureNCT00269230
Attain StarFix™ Model 4195 Left Ventricular Lead
A study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing Lead
- Type of treatment
- Medical device
- How many people
- 441 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Jul 2004to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States20 sites
Study site
Atlanta, Georgia
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Germantown, Tennessee
Study site
Grand Rapids, Michigan
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Lincoln, Nebraska
Study site
Long Beach, California
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
Newark, Delaware
Study site
Newark, New Jersey
Study site
Orlando, Florida
Study site
Palo Alto, California
Study site
Rochester, New York
Study site
Saginaw, Michigan
Study site
Saint Paul, Minnesota
Study site
St Louis, Missouri
Study site
Temple, Texas
Canada4 sites
Study site
Calgary, Alberta
Study site
London, Ontario
Study site
Sainte-Foy, Quebec
Study site
Victoria, British Columbia
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Pacing Lead
- Keywords
- cardiac resynchronization therapy, left ventricular Lead, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing LeadDevice
Left ventricular pacing lead
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy at 3 months
Measured: 3 Months
Secondary outcomes (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
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stuart W Adler II, MD, Principal investigator, St. Paul Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269230
- Sponsor's protocol ID
- 234
- Status last verified
- Oct 2008
- First submitted
- 21 Dec 2005
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain StarFix™ Model 4195 Left Ventricular Lead
- ClinicalTrials.gov ID
- NCT00269230
- Acronym / sponsor ID
- 234
- Conditions
- Heart Failure
- Keywords
- cardiac resynchronization therapy, left ventricular Lead, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing LeadLeft ventricular pacing lead | Device | – |
Primary outcome
Safety and Efficacy at 3 months
Time frame: 3 Months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart W Adler II, MD principal investigator
St. Paul Heart Clinic
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy at 3 months (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2008.