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Heart FailureNCT01361685

Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

An observational study of Heart Failure, run by Medtronic at 52 sites in 3 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

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
366 participants
Where
52 sitesin 3 countries
Study dates
May 2011to 4 Feb 2021
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 4396 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 4396 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

52 sites in 3 countries.

52 sites in 3 countries

United States48 sites

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Cenla Heart Specialists

    Alexandria, Louisiana, 71301

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Our Lady of the Lake Office of Research

    Baton Rouge, Louisiana, 70808

  • Lehigh Valley Health Network

    Bethlehem, Pennsylvania, 18017

  • Bradenton Cardiology

    Bradenton, Florida, 34205

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • The Christ Hospital Health Network

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Metropolitan Cardiology Consultants PA

    Coon Rapids, Minnesota, 55433

  • Baylor Research Institute

    Dallas, Texas, 75206

  • Medicor Associates

    Erie, Pennsylvania, 16507

  • Southwest EP Clinic

    Gilbert, Arizona, 85295

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Indiana University Health - Methodist Research Institute

    Indianapolis, Indiana, 46202

  • Baptist Heart Specialists

    Jacksonville, Florida, 32216

  • Saint Lukes Health System

    Kansas City, Missouri, 64111

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Colorado Heart and Vascular, PC

    Lakewood, Colorado, 80228

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17603

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205

  • Louisville Cardiology Group

    Louisville, Kentucky, 40207

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205

  • Yale University

    New Haven, Connecticut, 06519

  • NYU Langone Medical Center

    New York, New York, 10016

  • New York-Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065

  • Baylor Research Institute

    Plano, Texas, 75093

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California, 92270

  • North Memorial Heart and Vascular Institute

    Robbinsdale, Minnesota, 55422

  • HealthCare Partners Medical Group

    Saint Louis Park, Minnesota, 55416

  • STAR Clinical Trials

    San Antonio, Texas, 78229

  • Washington University

    St Louis, Missouri, 63110

  • EP Heart LLC

    The Woodlands, Texas, 77384

  • COR Healthcare

    Torrance, California, 90503

  • Central New York Cardiology

    Utica, New York, 13501

  • Cardiovascular Consultants Medical Group

    Van Nuys, California, 91405

  • Patients First Health Care LLC

    Washington, Missouri, 63090

  • MedStar Southern Maryland Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • New Jersey Cardiology Associates

    West Orange, New Jersey, 07052

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada3 sites

  • Queen's University & Kingston General Hospital

    Kingston, Ontario, K7L 3N6

  • Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu

    Montreal, Quebec, H2W 1T8

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

    Québec, G1V 4G5

Other trials in Canada

Germany1 site

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

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 4396 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 4396 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 4396 LV Lead-related complication rate

    Measured: 5 years

Secondary outcomes (6)

  1. Types of lead-related adverse device effects

    Measured: 5 years

  2. Percent of subjects with changes in electrode programming

    Measured: 5 years

  3. Number of fractures with and without loss of function

    Measured: 5 years

  4. Bipolar electrical performance at 1 year

    Measured: 1 year

  5. Bipolar pacing impedance

    Measured: 1 year

  6. Bipolar pacing capture threshold

    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 completion2 Mar 2020
  4. Study completion4 Feb 2021

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
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01361685
Sponsor's protocol ID
4396 Chronic Performance
Status last verified
Feb 2021
First submitted
25 May 2011
Last updated
17 Feb 2021
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 52 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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 4396 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 NCT01361685.

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 17 Feb 2021.

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Clinical Trial NCT01361685 | AzTrials