Ventricular TachycardiaNCT01638897
DF4 Connector System Post-Approval Study
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Medtronic at 78 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death
- How many people
- 1,778 participants
- Where
- 78 sitesin 3 countries
- Study dates
- Jan 2012to Mar 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 intended to be implanted or are within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Who may be able to join
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application
Who cannot join
- Subject who is, or will be inaccessible for follow-up at a study site
- Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
- Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
Trial locations and contacts
78 sites in 3 countries.
78 sites in 3 countries
United States72 sites
Study site
Akron, Ohio
Study site
Albany, Georgia
Study site
Albuquerque, New Mexico
Study site
Allentown, Pennsylvania
Study site
Anchorage, Alaska
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Bradenton, Florida
Study site
Burlington, Vermont
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, Missouri
Study site
Des Moines, Iowa
Study site
Durham, North Carolina
Study site
Edgewood, Kentucky
Study site
Erie, Pennsylvania
Study site
Garden City, New York
Study site
Germantown, Tennessee
Study site
Gilbert, Arizona
Study site
Henderson, Nevada
Study site
Huntington, New York
Study site
Hyattsville, Maryland
Study site
Indianapolis, Indiana
Study site
Jonesboro, Arkansas
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Kingsport, Tennessee
Study site
Lakewood, Colorado
Study site
Lancaster, Pennsylvania
Study site
Lansing, Michigan
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Marquette, Michigan
Study site
Milwaukee, Wisconsin
Study site
Morristown, New Jersey
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newark, Delaware
Study site
Olympia, Washington
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Plano, Texas
Study site
Poughkeepsie, New York
Study site
Raleigh, North Carolina
Study site
Rancho Mirage, California
Study site
Robbinsdale, Minnesota
Study site
Saint Louis Park, Minnesota
Study site
Saint Paul, Minnesota
Study site
Salinas, California
Study site
San Diego, California
Study site
San Francisco, California
Study site
Scottsdale, Arizona
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
Tacoma, Washington
Study site
Takoma Park, Maryland
Study site
The Woodlands, Texas
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Utica, New York
Study site
Van Nuys, California
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
Study site
Worcester, Massachusetts
Canada5 sites
Study site
Calgary, Alberta
Study site
Kingston, Ontario
Study site
Montreal, Quebec
Study site
Québec, Quebec
Study site
Trois-Rivières, Quebec
About this study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
- Keywords
- ICD, CRTD, DF4
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
DF4 Lead Related Complication Rate
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
Measured: Up to 5 Years
Secondary outcomes (5)
Types of DF4 lead related events
Number of DF4 lead related events grouped by type
Measured: Up to 5 years
Bipolar pacing impedance (ohms)
Summary statistics at 5 years post-implant will be reported.
Measured: 5 years
High voltage impedance (ohms)
Summary statistics at 5 years post-implant will be reported
Measured: 5 years
Pacing threshold (volts)
The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported.
Measured: 5 years
Sensing amplitude (millivolts)
The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638897
- Sponsor's protocol ID
- DF4
- Status last verified
- Mar 2019
- First submitted
- 3 Jul 2012
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DF4 Connector System Post-Approval Study
- ClinicalTrials.gov ID
- NCT01638897
- Acronym / sponsor ID
- DF4
- Keywords
- ICD, CRTD, DF4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,778 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients intended to be implanted or are within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Key inclusion criteria (2 listed)
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application
Key exclusion criteria (3 listed)
- Subject who is, or will be inaccessible for follow-up at a study site
- Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
- Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
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
DF4 Lead Related Complication Rate
Time frame: Up to 5 Years
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
5 secondary outcomes
Types of DF4 lead related events
Time frame: Up to 5 years
Bipolar pacing impedance (ohms)
Time frame: 5 years
High voltage impedance (ohms)
Time frame: 5 years
Pacing threshold (volts)
Time frame: 5 years
Sensing amplitude (millivolts)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Medtronic at 78 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 2 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Canada, France. 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?
DF4 Lead Related Complication Rate (time frame: Up to 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2019.