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Heart FailureNCT00271544

Attain Model 4196 Left Ventricular (LV) Lead

A study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
24 sitesin 2 countries
Study dates
Feb 2007to Dec 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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

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

24 sites in 2 countries.

24 sites in 2 countries

United States19 sites

  • Study site

    Anchorage, Alaska

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Burlington, Vermont

  • Study site

    Dallas, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Detroit, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Memphis, Tennessee

  • Study site

    Minneapolis, Minnesota

  • Study site

    Palo Alto, California

  • Study site

    Phoenix, Arizona

  • Study site

    Raleigh, North Carolina

  • Study site

    Spartanburg, South Carolina

  • Study site

    Wynnewood, Pennsylvania

Other trials in United States

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

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).

Conditions
Heart Failure
Being tested
Pacing Lead
Keywords
heart failure, cardiac pacing, left ventricular lead, cardiac resynchronization therapy
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

    implant and follow-up of study device

Study groups in NCT00271544
Study groupRoleWhat they receive
4196 LeadExperimentalNon-randomized study.
Receives: Device: Pacing Lead

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One Month

  2. Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)

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

    Measured: One Month

  3. Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)

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

    Measured: Three Months

Secondary outcomes (16)

  1. Subjects Successfully Implanted With Model 4196 Lead

    A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.

    Measured: Implant

  2. Subjects Successfully Implanted After Cannulation

    A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.

    Measured: Implant

  3. All Left Ventricular Leads

    All left ventricular leads successfully implanted

    Measured: Implant

  4. All Medtronic Left Ventricular Leads (Attain Family)

    All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted

    Measured: Implant

  5. Cannulation Time

    Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.

    Measured: Implant

  6. Fluoroscopy Time

    Fluoroscopy time was defined as the total time the fluoroscope was imaging.

    Measured: Implant

  7. Model 4196 Lead Placement Time

    Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.

    Measured: Implant

  8. Total Implant Time

    Total implant time was defined as time from initial incision to final closure.

    Measured: Implant

  9. Assessment of Lead Handling Characteristics

    Lead handling characteristics assessed as "acceptable" by physicians

    Measured: Implant

  10. Electrical Performance - Tip Electrode: Sensing

    Model 4196 lead tip electrode R-wave amplitude

    Measured: 12-month

  11. Electrical Performance - Tip Electrode: LV Voltage Threshold

    Model 4196 lead tip electrode LV voltage threshold

    Measured: 12-month

  12. Electrical Performance -Tip Electrode: Pacing Impedance

    Model 4196 lead tip electrode pacing impedance

    Measured: 12-month

  13. Electrical Performance -Ring Electrode: Sensing

    Model 4196 lead ring electrode R-wave amplitude

    Measured: Implant

  14. Electrical Performance - Ring Electrode: LV Voltage Threshold

    Model 4196 lead ring electrode LV voltage threshold

    Measured: 12-month

  15. Electrical Performance -Ring Electrode: Pacing Impedance

    Model 4196 lead ring electrode pacing impedance

    Measured: 12-Month

  16. Summarize All Adverse Events

    All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionAug 2007
  4. Study completionDec 2008

Resources

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
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00271544
Sponsor's protocol ID
241
Status last verified
Sep 2009
First submitted
28 Dec 2005
Last updated
28 Sep 2009
Data monitoring committee
No

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 24 sites in 2 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 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 25 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (Subjects Without a Model 4196 Lead Related Complication) (time frame: One Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00271544.

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 28 Sep 2009.

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