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AzTrials

Heart FailureNCT01361672

Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

An observational study of Heart Failure, run by Medtronic at 99 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

Lead survivability will be summarized. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Failure
How many people
1,140 participants
Where
99 sitesin 3 countries
Study dates
May 2011to Jul 2019
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients implanted with a 4296 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Who may be able to join

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain Ability Model 4296 LV lead
  • Patient within 30 day post implant enrollment window

Who cannot join

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Trial locations and contacts

99 sites in 3 countries.

99 sites in 3 countries

United States94 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Austin, Texas, 78705

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Chandler, Arizona, 85226

  • Study site

    Chula Vista, California, 91910

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Columbia, Missouri, 65201

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Dallas, Texas, 75226

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Durham, North Carolina, 27705

  • Study site

    Erie, Pennsylvania, 16550

  • Study site

    Falls Church, Virginia, 22042

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Garden City, New York, 11530

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Gilbert, Arizona, 85295

  • Study site

    Greensboro, North Carolina, 27610

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntington, New York, 11743

  • Study site

    Hyattsville, Maryland, 20782

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jonesboro, Arkansas, 72410

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Lancaster, Pennsylvania, 17604

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Lebanon, New Hampshire, 03766

  • Study site

    Leesburg, Virginia, 20176

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Marquette, Michigan, 49855

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Monterey, California, 93940

  • Study site

    Morristown, New Jersey, 07960

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Haven, Connecticut, 06519

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    Newark, Delaware, 19713

  • Study site

    Ocean City, New Jersey, 07712

  • Study site

    Olympia, Washington, 98506

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plano, Texas, 75093

  • Study site

    Poughkeepsie, New York, 12601

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Redding, California, 96001

  • Study site

    Redwood City, California, 94062

  • Study site

    Robbinsdale, Minnesota, 55422

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Safety Harbor, Florida, 34695

  • Study site

    Saint Louis Park, Minnesota, 55416

  • Study site

    Salinas, California, 93901

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94143

  • Study site

    Silver Spring, Maryland, 20910

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stanford, California, 94305

  • Study site

    Tacoma, Washington, 98402

  • Study site

    Takoma Park, Maryland, 20912

  • Study site

    Tampa, Florida, 33607

  • Study site

    The Woodlands, Texas, 77384

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Torrance, California, 90503

  • Study site

    Utica, New York, 13501

  • Study site

    Van Nuys, California, 91405

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    West Orange, New Jersey, 07052

  • Study site

    Wilkes-Barre, Pennsylvania, 18711

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Worcester, Massachusetts, 01605

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada4 sites

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Ottawa, Ontario, K1Y 4W7

  • Study site

    Peterborough, Ontario, K9J 0B2

  • Study site

    Québec, Quebec, G1V 4G5

Other trials in Canada

Germany1 site

  • Study site

    Essen, 45147

Other trials in Germany

About this study

Official title: Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Lead survivability will be summarized.

Read the detailed description

The purpose of this study is to evaluate long-term performance of the 4296 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Conditions
Heart Failure
Medical subject headings
Heart Failure

What is being measured

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

  1. Model 4296 LV Lead-related complication rate

    To demonstrate that the Model 4296 lead-related complication-free probability

    Measured: 5 years

Secondary outcomes (6)

  1. Types of lead-related adverse device effects

    To summarize all lead related adverse events

    Measured: 5 years

  2. Percent of subjects with changes in electrode programming

    To characterize any changes in electrical programming

    Measured: 5 years

  3. Number of fractures with and without loss of function

    To characterize fractures with and without loss of function

    Measured: 5 years

  4. Bipolar electrical performance at 1 year

    To summarize bipolar electrical performance at one year post implant

    Measured: 1 year

  5. Bipolar pacing impedance

    To characterize threshold measurements and impedance for both conductors

    Measured: 1 year

  6. Bipolar pacing capture threshold

    To characterize standard bipolar pacing voltage thresholds

    Measured: 1 year

Timeline

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

  1. First posted27 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJul 2019
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01361672
Sponsor's protocol ID
4296 Chronic Performance
Status last verified
Jul 2019
First submitted
25 May 2011
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Medtronic at 99 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 3 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada, Germany. 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?

Model 4296 LV Lead-related complication rate (time frame: 5 years). 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 NCT01361672.

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 22 Jul 2019.

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