AzTrials
AzTrials

Optim Lead Insulation Related Adverse EventsOPTIMUMNCT01722188

Lead Registry for Optim Leads

An observational study of Optim Lead Insulation Related Adverse Events, run by Abbott Medical Devices at 261 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

This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry. Read more about this study

Who is it for?
Ages 18 years and older
How many people
14,124 participants
Where
261 sitesin 3 countries
Study dates
Aug 2006to Jul 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients implanted with market released SJM Optim lead and a compatible market released CRM implantable pulse generator (pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy device (CRT)) is eligible for enrollment into the registry.

Who may be able to join

  • Patient has a standard indication for a CRM implantable pulse generator.
  • Patient receives a market released SJM Optim lead at implant.
  • Patient receives a market released CRM implantable pulse generator at implant.
  • Patient is willing to provide authorization for registry participation.
  • Complete device implant information, including any Optim lead related adverse event is available

Who cannot join

  • Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months).
  • Patient is < 18 years of age.
  • Patient has a life expectancy of < 2 years (malignancies)

Trial locations and contacts

261 sites in 3 countries.

261 sites in 3 countries

United States245 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Heart South Cardiovascular Group PC

    Alabaster, Alabama, 35007

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Freedman Memorial Cardiology

    Alexandria, Louisiana, 71301

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • Cumberland Cardiology

    Ashland, Kentucky, 41101

  • Athens Heart Center

    Athens, Georgia, 30606

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • St. Mary's

    Athens, Georgia, 30606

  • Piedmont Heart Institute - Buckhead Location

    Atlanta, Georgia, 30309

  • Fox Valley Cardiovascular Consultants

    Aurora, Illinois, 60504

  • Heart Rhythm Consultants

    Austin, Texas, 78705

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • City Cardiology Associates

    Barberton, Ohio, 44203

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • Bay City Cardiology Clinic at Matagorda General Hospital

    Bay City, Texas, 77404

  • Southeast Texas Cardiology

    Beaumont, Texas, 77702

  • Bellevue Cardiology

    Bellevue, Washington, 98004

  • Overlake Internal Medicine Associates

    Bellevue, Washington, 98004

  • National Naval Medical Center

    Bethesda, Maryland, 20889

  • Westside Cardiovascular Associates

    Beverly Hills, California, 90211

  • Coast Cardiovascular Consultants

    Biloxi, Mississippi, 39532

  • Cardiology and Arrhythmia Consultants P.C.

    Birmingham, Michigan, 48009

  • Cardiac Arrhythmia Services

    Boca Raton, Florida, 33422

  • Bradenton Heart Center

    Bradenton, Florida, 34209

  • Bay Area Cardiology Associates PA

    Brandon, Florida, 33511

  • Kitsap Cardiology Consultants

    Bremerton, Washington, 98310

  • Florida Cardiology Group

    Brooksville, Florida, 34613

  • Raymond Schaerf, MD

    Burbank, California, 91505

  • Mills-Peninsula Cardiovascular Specialists

    Burlingame, California, 94010

  • SouthWestern Pennsylvania Cardiovascular Associates

    Butler, Pennsylvania, 16001

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Cardiovascular Consultants of Cape Girardeau Inc

    Cape Girardeau, Missouri, 63703

  • Charleston Cardiology

    Charleston, South Carolina, 29403

  • Coastal Cardiology

    Charleston, South Carolina, 29407

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Chattanooga Heart Institute

    Chattanooga, Tennessee, 37404

  • South Jersey Heart Group

    Cherry Hill, New Jersey, 08002

  • Cardiovascular Associates Ltd

    Chesapeake, Virginia, 23320

  • Pinellas Arrhythmia Associates

    Clearwater, Florida, 33756

  • BCS Heart, LLP

    College Station, Texas, 77845

  • Penrose St. Francis Cardiology Associates PC

    Colorado Springs, Colorado, 80907

  • Pikes Peak Cardiology

    Colorado Springs, Colorado, 80909

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Electrophysiology & Pacing Interventionalists

    Columbus, Ohio, 43222

  • Electrophysiology and Pacing Interventionalists

    Columbus, Ohio, 43222

  • Cardiovascular Associates

    Covington, Louisiana, 70433

  • Covington Cardiovascular Care

    Covington, Louisiana, 70433

  • St. Tammany Heart and Vascular

    Covington, Louisiana, 70433

  • Okaloosa Heart and Vascular

    Crestview, Florida, 32539

  • Dallas Heart Group

    Dallas, Texas, 75230

  • North Texas Heart Center

    Dallas, Texas, 75231-3833

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9016

  • Cardiology Consultants PA

    Daytona Beach, Florida, 32114

  • The Cardiology Center, Incorporated

    Delray Beach, Florida, 33484

  • Harvard Park Medical

    Denver, Colorado, 80210

  • Unitypoint

    Des Moines, Iowa, 50316

  • St. Luke's Cardiology Associates

    Duluth, Minnesota, 55802

  • Cardiology Care Consultants

    El Paso, Texas, 79936

  • Provena Saint Joseph Hospital

    Elgin, Illinois, 60123

  • University Hospitals Elyria Medical Center

    Elyria, Ohio, 44035

  • Center for Interventional Cardiology and Nephrology

    Encino, California, 91436

  • Ohio Valley Heart Care

    Evansville, Indiana, 47714

  • The Cardiovascular Group

    Fairfax, Virginia, 22031

  • Mercy Hospital Fairfield

    Fairfield, Ohio, 45014

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Sanford Research

    Fargo, North Dakota, 58112

  • Hunterdon Cardiovascular Associates

    Flemington, New Jersey, 08822

  • Baystate Medical Practice

    Florence, Massachusetts, 01062

  • Pee Dee Cardiology Associates, PA

    Florence, South Carolina, 29506

  • The Heart Care Group

    Florissant, Missouri, 63031

  • Appalachian Cardiovascular Associates

    Fort Payne, Alabama, 35968

  • White-Wilson Medical Center - Fort Walton Beach

    Fort Walton Beach, Florida, 32547

  • Texas Heart Clinic, PA

    Fort Worth, Texas, 76104

  • Cardiac Institute

    Fresno, California, 93650

  • Mid Valley Cardiology

    Fresno, California, 93720

  • North Alabama Cardiology Center

    Gadsden, Alabama, 35903

  • The Cardiac & Vascular Institute Research Foundation, LLC

    Gainesville, Florida, 32605

  • Shands at the University of Florida

    Gainesville, Florida, 32610

  • Northeast Georgia Heart Foundation

    Gainesville, Georgia, 30501

  • Cardiac Care Specialists

    Glendale, California, 91203

  • Glendale Memorial Hospital and Medical Center

    Glendale, California, 91204

  • Adirondack Cardiology Associates

    Glens Falls, New York, 12801

  • Wayne Heart Internal Medicine

    Goldsboro, North Carolina, 27534

  • Regional Cardiology Associates, PLC

    Grand Blanc, Michigan, 48439

  • Altru Clinic - Main

    Grand Forks, North Dakota, 58201

  • Cardiology Associates of Green Bay, Ltd.

    Green Bay, Wisconsin, 54301-3528

  • Piedmont Cardiology

    Greenwood, South Carolina, 29646

  • Coast Cardiology Center

    Gulfport, Mississippi, 39503

  • Hamilton Cardiology Associates

    Hamilton, New Jersey, 08690

  • Saint Margaret Mercy Healthcare Centers

    Hammond, Indiana, 46320

  • Riverside Heart Specialists

    Hampton, Virginia, 23666

  • Harrisonburg Medical Associations, Inc.

    Harrisonburg, Virginia, 22801

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Piedmont Cardiology Associates

    Hickory, North Carolina, 28602

  • Florida Institute For Cardiovascular Care

    Hollywood, Florida, 33021

  • Center for Cardiac Arrhythmias

    Houston, Texas, 77030

  • EP/Cardiology PA

    Houston, Texas, 77030

  • Willowbrook Cardiovascular Associates

    Houston, Texas, 77030

  • Cardiovascular Association, P.L.L.C.

    Humble, Texas, 77338

  • The Cardiovascular Specialists

    Hyannis, Massachusetts, 02601

  • Apex Cardiology

    Inglewood, California, 90301

  • River Cities Cardiology

    Jeffersonville, Indiana, 47130

  • Mountain States Medical Group Cardiology

    Johnson City, Tennessee, 37601

  • Cardiovascular Consultants (now St. Luke's)

    Kansas City, Missouri, 64111

  • East Tennessee Heart Consultants - Knoxville

    Knoxville, Tennessee, 37920

  • Knoxville Cardiovascular Research Group, LLC

    Knoxville, Tennessee, 37922

  • Heart and Vascular Institute of LA LLC

    Lacombe, Louisiana, 70445

  • Mike Mounir MD

    Lafayette, Louisiana, 70503

  • Cardiovascular Specialists of SWLA

    Lake Charles, Louisiana, 70601

  • Imperial Health, LLP

    Lake Charles, Louisiana, 70601

  • Jorge Diaz, M.D., P.A.

    Lake Mary, Florida, 32746

  • Clark & Daughtrey Medical Group, PA

    Lakeland, Florida, 33806-2098

  • Kartik Thaker, MD Inc.

    Lakewood, California, 90712

  • Nevada Cardiology Associates

    Las Vegas, Nevada, 89109

  • Gwinnet Consultants in Cardiology

    Lawrenceville, Georgia, 30045

  • Cardiology Associates of Kentucky

    Lexington, Kentucky, 40504

  • Arkansas Cardiology

    Little Rock, Arkansas, 72205

  • *Little Rock Cardiology Clinic

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Omid Vahdat M.D.

    Los Alamitos, California, 90720

  • Donna Gallik MD

    Los Angeles, California, 90048

  • Jeffrey Goodman MD

    Los Angeles, California, 90048

  • Payam Yashar M.D.

    Los Angeles, California, 90067

  • Bluegrass Cardiology

    Louisville, Kentucky, 40215

  • Texas Cardiac Center

    Lubbock, Texas, 79410

  • Dean Foundation

    Madison, Wisconsin, 53715

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Baptist Health Medical Group, Inc.

    Madisonville, Kentucky, 42431

  • Kennestone Heart Physicians

    Marietta, Georgia, 30060

  • Cardiology Center

    Marrero, Louisiana, 70072

  • Diagnostic and Interventional Cardiology

    Melbourne, Florida, 32901

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Arrhythmia Consultants, P.C.

    Memphis, Tennessee, 38104

  • Miami International Cardiology Consultants Inc

    Miami Beach, Florida, 33140

  • Permian Cardiology Associates

    Midland, Texas, 79761

  • Long Island Heart Associates

    Mineola, New York, 11501

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55455

  • Stephen S. Ehrlich, MD

    Mission Viejo, California, 92691

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608

  • Gregory C. Sampognaro Interventional Cardiology

    Monroe, Louisiana, 71201

  • Atlantic Health System - Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Skagit Valley Medical Center

    Mount Vernon, Washington, 98274

  • Medical Consultants

    Muncie, Indiana, 47303

  • Cardiology Associates of NW Indiana

    Munster, Indiana, 46321

  • Inland Valley Cardiovascular Center

    Murrieta, California, 95263

  • Grove Hill Medical Center

    New Britain, Connecticut, 06052

  • Mehrdad Ariani MD

    Northridge, California, 91325

  • Soltera Yasuda & Associates

    Northridge, California, 91325

  • Cardiology Associates of Fairfield County, PC

    Norwalk, Connecticut, 06851

  • MidAmerica Cardiovascular Consultants

    Oak Lawn, Illinois, 60453

  • Institute of Cardiovascular Research LLC

    Ocala, Florida, 34471

  • Ram Vasudevan, MD, FACC

    Ocala, Florida, 34471

  • Central Florida Heart Center

    Ocala, Florida, 34474

  • Monmouth Cardiology Associates, LLC

    Ocean City, New Jersey, 07712

  • Odessa Heart Institute, P. A.

    Odessa, Texas, 79761

  • Khastgir, Terrance M.D.

    Oklahoma City, Oklahoma, 73112

  • Methodist Physicians Clinic-Heart Consultants

    Omaha, Nebraska, 68114

  • Alegent Creighton Health

    Omaha, Nebraska, 68124

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Miguel E. Castellanos, MD

    Orange, Texas, 77630

  • Cardiovascular Interventions, P.A.

    Orlando, Florida, 32803

  • Mid-Florida Cardiology Specialist

    Orlando, Florida, 32806

  • Cardiology Research Associates

    Ormond Beach, Florida, 32174

  • Cabrillo Cardiology Medical Group

    Oxnard, California, 93030

  • Alejandro Garcia MD

    Oxnard, California, 93036

  • Cardio Care Center

    Palatka, Florida, 32177

  • Desert Heart Physicians

    Palm Springs, California, 92262

  • Southern California Heart Specialists

    Pasadena, California, 91105

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Wake Heart Associates

    Raleigh, North Carolina, 27610

  • William A Stellar, MD

    Rancho Mirage, California, 92270

  • Cardiac Rhythm Specialists, Inc.

    Reseda, California, 91335

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23229

  • Hunter Holmes McGuire VAMC

    Richmond, Virginia, 23249

  • Heart Center of Riverside

    Riverside, California, 34232

  • Academic Cardiology Associates

    Rochester Hills, Michigan, 48307

  • Rockford Cardiology Associates

    Rockford, Illinois, 61107

  • Cardiac Associates PC

    Rockville, Maryland, 20850

  • Harbin Clinic Southeastern Cardiovascular Institute

    Rome, Georgia, 30165

  • Cardiac Arrhythmia and Pacemaker Center

    Roslyn, New York, 11576

  • Mercy Medical Group Cardiology

    Sacramento, California, 95816

  • St. Augustine Cardiology Associates

    Saint Augustine, Florida, 32086

  • Salinas Valley Memorial Hospital

    Salinas, California, 93901

  • Delmarva Heart

    Salisbury, Maryland, 21804

  • Peninsula Cardiology Associates, P.A.

    Salisbury, Maryland, 21804

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Cardiology Clinic Of San Antonio Pa

    San Antonio, Texas, 78229

  • Brooke Army Medical Center, Division of Cardiology

    San Antonio, Texas, 78234

  • Dubois Regional Cardiology Associates

    Sandy, Pennsylvania, 15801

  • Bruce A. Ourieff MD

    Santa Maria, California, 93454

  • Heart Care Research

    Sarasota, Florida, 34232

  • Sarasota Heart Center

    Sarasota, Florida, 34239

  • Sarasota Arrhythmia Institute

    Sarasota, Florida, 34321

  • Donald Guthrie Foundation for Education and Research

    Sayre, Pennsylvania, 18840

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111

  • Cardiology Associates Incorporated

    Shreveport, Louisiana, 71105

  • Alan Schneider

    Silver Spring, Maryland, 20902

  • Heart Cardiology Consultants

    Southfield, Michigan, 48075

  • Sacred Heart Medical Center

    Spokane, Washington, 99202

  • Kootenai Heart Clinics

    Spokane, Washington, 99204

  • Northwest Cardiology

    Springdale, Arkansas, 72764

  • Ohio Institute Of Cardiac Care

    Springfield, Ohio, 45504

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • County Cardiology, Inc.

    St Louis, Missouri, 63128

  • The Heart Health Center

    St Louis, Missouri, 63141-6835

  • St. Louis Cardiology Consultants

    St Louis, Missouri, 63146

  • Heart Care Cardiology Consultants, Inc.

    Steubenville, Ohio, 43952

  • Riverside Medical of Ohio

    Steubenville, Ohio, 43952

  • Dr. Kalpesh Solanki

    Summerfield, Florida, 34491

  • Sun City Cardiology Medical Center, Incorporated

    Sun City, California, 92586

  • Sun City Cardiology Medical Center, Inc

    Sun City, California, 92586

  • Franciscan Cardiology Associates

    Tacoma, Washington, 98405

  • Franciscan Heart & Vascular Associates

    Tacoma, Washington, 98405

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Mazhar Majid, M.D.

    Tamarac, Florida, 33321

  • Michael Burnam, MD

    Tarzana, California, 91356

  • Richard P. Cain, MD

    Tarzana, California, 91356

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Northwest Ohio Cardiology Consultants

    Toledo, Ohio, 43615

  • Toledo Clinic

    Toledo, Ohio, 43623

  • COR Healthcare Medical Associates

    Torrance, California, 90505

  • Grand Traverse Heart Associates

    Traverse City, Michigan, 49684

  • Pima Heart Physicians, PC

    Tucson, Arizona, 85712

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Cardiovascular Consultants, Inc.

    Tulsa, Oklahoma, 74136

  • Cardiovascular Associates of East Texas

    Tyler, Texas, 75701

  • South Georgia Cardiology PC

    Valdosta, Georgia, 31602

  • Cardiovascular Consultants

    Van Nuys, California, 91405

  • Arash Vahdat, MD

    Van Nuys, California, 91406

  • Heart & Vascular Center of Venice

    Venice, Florida, 34292

  • Victoria Heart and Vascular

    Victoria, Texas, 77901

  • Lingareddy Devireddy, PC

    Warren, Michigan, 48093

  • Cardiology Consultants of North Jersey

    Wayne, New Jersey, 07470

  • New Jersey Cardiology Associates

    West Orange, New Jersey, 07052

  • Shiva Heart Center Medical Group

    Wildomar, California, 92595

  • Fallon Clinic

    Worcester, Massachusetts, 01608

  • Heart Rhythm Specialists of Central Massachusetts, PC

    Worcester, Massachusetts, 01608

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

  • Ohio Heart Institute

    Youngstown, Ohio, 44504

  • Cardiac Arrhythmia Associates

    Youngstown, Ohio, 44505

  • Feather River Cardiovascular Institute

    Yuba City, California, 95991

  • Yuba Sutter Medical Clinic

    Yuba City, California, 95991

Other trials in United States

Germany15 sites

  • Praxis Dr. med. Bernhardt

    Annaberg-Buchholz, Saxony, 9456

  • Praxis Dr. med. Irtel von Brenndorff

    Baden-Baden, Bad-wur, 76532

  • Praxis Dr. Med. Stellmach

    Chemnitz, Saxony, 09126

  • Praxis Dr. med. Thomas Fadgyas

    Dortmund, N. RHIN, 44137

  • Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang

    Erfurt, Thurgia, 99084

  • Helios-Klinikum Erfurt GmbH

    Erfurt, Thurgia, 99089

  • Praxis Dr. med. Markert

    Gaggenau, Bad-wur, 76571

  • Asklepios Klinik St. Georg

    Hamberg, 20099

  • Asklepios Klinik Nord Heidberg-Ochsenzoll

    Hamberg, 22417

  • Asklepios Klinik Altona

    Hamberg, 22763

  • Praxis Dr. med. Subin

    Hamburg, 20095

  • Praxis Dr. med. Behroz

    Heidelberg, Bad-wur, 69123

  • Praxis Frau Dr. med. Strucks

    Nossen, Saxony, 01683

  • Kreiskrankenhaus des Bördekreises Krankenhaus 4

    Oschersleben, Sxnyanh, 39387

  • Klinikum Pirna GmbH Klinik für Innere Medizin II

    Pirna, Saxony, 1796

Other trials in Germany

Belgium1 site

  • CHR Citadelle

    Liège, 4000

Other trials in Belgium

About this study

Official title: Optim Lead Insulation Material Registry

This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.

Read the detailed description

Patients are enrolled in the registry up to 180 days post implantation of an Optim lead. Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are followed indefinitely following enrollment. Patients with other Optim leads are followed for a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is based on the established follow-up practices currently used by each of the respective registry centers. Patients are followed according to the center's standard follow-up schedule.

At each office/clinic follow-up visit standard electrical measurements are collected. During system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex® µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy or chest X-ray is performed according to the site's standard of care then copies of those should be submitted.

Keywords
Optim, Insulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01722188
Study groupRoleWhat they receive
Optim LeadsNot described

What is being measured

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

  1. Survival from insulation related adverse events

    Measured: 5 years

Timeline

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

  1. First posted6 Nov 2012 (estimated)
  2. Study startAug 2006
  3. Primary completionJul 2020
  4. Study completionJul 2020

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
Case only
Time perspective
Prospective
Enrolment
14,124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722188
Sponsor's protocol ID
CD0196
Acronym
OPTIMUM
Status last verified
May 2021
First submitted
2 Nov 2012
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Optim Lead Insulation Related Adverse Events, run by Abbott Medical Devices at 261 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 5 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in United States, Germany, Belgium. 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?

Survival from insulation related adverse events (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 NCT01722188.

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 11 May 2021.

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