Arrhythmia4968NCT01076361

Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

An observational study of Arrhythmia and Heart Failure, run by Medtronic at 106 sites in 14 countries.

Completed

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

Trial summary

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study. Read more about this study

Who is it for?: Any age
Conditions the study is for: Arrhythmia, Heart Failure
How many people: 370 participants
Where: 106 sitesin 14 countries
Study dates: Sep 1999to Sep 2010
How long will I take part?: 5 Years
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Subjects implanted with a 4968 lead.

Who may be able to join

Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
Availability of implant, follow-up, and product-related event data
Implanted with a Model 4968 Capsure Epi Lead

Who cannot join

Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
Subjects with exclusion criteria required by local law

Trial locations and contacts

106 sites in 14 countries.

Country

City, postcode or hospital

106 sites in 14 countries

United States83 sites

Study site
Albuquerque, New Mexico
Study site
Alexandria, Louisiana
Study site
Amarillo, Texas
Alaska Heart Institute
Anchorage, Alaska
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bakersville, California
Study site
Baton Rouge, Louisiana
Study site
Browns Mills, New Jersey
Study site
Burlington, Vermont
Study site
Chattanooga, Tennessee
Study site
Chesapeake, Virginia
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Columbia, South Carolina
Study site
Columbus, Georgia
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Des Moines, Iowa
Study site
Downey, California
Study site
Doylestown, Pennsylvania
Study site
East Palo Alto, California
Study site
Fairfax, Virginia
Study site
Florence, South Carolina
Study site
Fort Worth, Texas
Study site
Germantown, Tennessee
Study site
Gilbert, Arizona
Study site
Grand Blanc, Michigan
Study site
Greensboro, North Carolina
Study site
Hickory, North Carolina
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Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Lebanon, New Hampshire
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Marquette, Michigan
Study site
Melbourne, Florida
Study site
Memphis, Tennessee
Study site
Milwaukee, Wisconsin
Study site
Mineola, New York
Study site
Nashville, Tennessee
Study site
Newark, New Jersey
Study site
Newburgh, Indiana
Study site
Oak Lawn, Illinois
Study site
Ocala, Florida
Study site
Ocean City, New Jersey
Study site
Olympia, Washington
Study site
Parlin, New Jersey
Study site
Portland, Oregon
Study site
Robbinsdale, Minnesota
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Saginaw, Michigan
Study site
Saint Paul, Minnesota
Study site
Salinas, California
Study site
Salisbury, Maryland
Study site
San Antonio, Texas
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Sayre, Pennsylvania
Study site
Scottsdale, Arizona
Study site
Silver Spring, Maryland
Study site
Sioux Falls, South Dakota
Study site
Southfield, Michigan
Study site
Spokane, Washington
Study site
The Woodlands, Texas
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Towson, Maryland
Study site
Van Nuys, California
Study site
Washington D.C., District of Columbia
Study site
Wellington, Florida
Study site
West Orange, New Jersey

Other trials in United States

Canada7 sites

Study site
Calgary, Alberta
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Regina, Saskatchewan
Study site
Ste-Foy, Quebec
Study site
Toronto, Ontario

Other trials in Canada

Italy3 sites

Study site
Catanzaro
Study site
Reggio Emilia
Study site
Udine

Other trials in Italy

Austria2 sites

Study site
Linz
Study site
Vienna

Other trials in Austria

Netherlands2 sites

Study site
Eindhoven
Study site
Rotterdam

Other trials in Netherlands

Australia1 site

Study site
Bedford Park, South Australia

Other trials in Australia

Belgium1 site

Study site
Hasselt

Other trials in Belgium

Denmark1 site

Study site
Copenhagen

Other trials in Denmark

France1 site

Study site
Marseille

Other trials in France

Germany1 site

Study site
Homburg/Saar

Other trials in Germany

Serbia and Montenegro1 site

Study site
Belgrade

Other trials in Serbia and Montenegro

Spain1 site

Study site
Valencia

Other trials in Spain

Sweden1 site

Study site
Skövde

Other trials in Sweden

Switzerland1 site

Study site
Zurich

Other trials in Switzerland

About this study

Official title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

Read the detailed description

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Conditions: Arrhythmia, Heart Failure
Keywords: Epicardial, Pacing Lead
Medical subject headings: Arrhythmias, Cardiac, Heart Failure

What is being measured

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

Survival Probability of the Model 4968 Lead Based on Lead-related Complications
The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.
Measured: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.

Timeline

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

Sep 1999Sep 2010

First posted26 Feb 2010 (estimated)
Study startSep 1999
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArrhythmiaStudies of the same condition, open and under way.
More trials run by MedtronicThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 370 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076361
Sponsor's protocol ID: 4968
Acronym: 4968
Status last verified: Oct 2014
First submitted: 24 Feb 2010
Last updated: 27 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

All Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study
ClinicalTrials.gov ID: NCT01076361
Acronym / sponsor ID: 4968 / 4968
Conditions: Arrhythmia, Heart Failure
Keywords: Epicardial, Pacing Lead
Study type: Observational
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: MedtronicIndustry (pharma, biotech, devices)
Study start: Sep 1999
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 27 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects implanted with a 4968 lead.

Key inclusion criteria (3 listed)

Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
Availability of implant, follow-up, and product-related event data
Implanted with a Model 4968 Capsure Epi Lead

Key exclusion criteria (4 listed)

Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
Subjects with exclusion criteria required by local law

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Survival Probability of the Model 4968 Lead Based on Lead-related Complications
Time frame: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.
The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.

Results and safety

Results posted to the registry on 27 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Model 4968 Leads	370	349

Primary outcome: Survival Probability of the Model 4968 Lead Based on Lead-related Complications

Time frame: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.. Number (95% Confidence Interval). Unit: percentage of Model 4968 Leads

Measure	Model 4968 Lead Survival Probability n = 349
Value	92.3 (88.3 to 95.04)

Population analysed: 22 Model 4968s (in 21 participants) was not available for analysis

Adverse events

Time frame: Post Implant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Model 4968 Participants	30 of 349 (8.6%)	0 of 349 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arrhythmia

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

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.

4968 Clinical Trial Leader study chair

Medtronic

106 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmia and Heart Failure, run by Medtronic at 106 sites in 14 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada, Italy, Austria, Netherlands and 9 more countries. 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 27 Oct 2014). 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?

Survival Probability of the Model 4968 Lead Based on Lead-related Complications (time frame: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.). 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 NCT01076361.

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 27 Oct 2014.