BradycardiaNCT01299675
SureScan Post-Approval Study
An observational study of Bradycardia, run by Medtronic at 61 sites in 2 countries.
Trial summary
The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bradycardia
- How many people
- 2,483 participants
- Where
- 61 sitesin 2 countries
- Study dates
- 8 Feb 2011to 2 Oct 2017
- 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 indicated for or implanted with a Medtronic SureScan Pacing System. 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 or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
- Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication
Who cannot join
- Subject who is, or will be inaccessible for follow-up
- Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
- Subject with exclusion criteria required by local law
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States59 sites
Study site
Akron, Ohio
Study site
Albuquerque, New Mexico
Study site
Atlanta, Georgia
Study site
Bakersfield, California
Study site
Bethlehem, Pennsylvania
Study site
Bradenton, Florida
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Columbus, Ohio
Study site
Coon Rapids, Minnesota
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
East Palo Alto, California
Study site
Elyria, Ohio
Study site
Erie, Pennsylvania
Study site
Evansville, Indiana
Study site
Falls Church, Virginia
Study site
Florence, South Carolina
Study site
Fort Lauderdale, Florida
Study site
Fort Sam Houston, Texas
Study site
Fort Worth, Texas
Study site
Fresno, California
Study site
Glendale, California
Study site
Henderson, Nevada
Study site
Hickory, North Carolina
Study site
Huntington, New York
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Marquette, Michigan
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Raleigh, North Carolina
Study site
Robbinsdale, Minnesota
Study site
Saint Louis Park, Minnesota
Study site
Saint Paul, Minnesota
Study site
Salinas, California
Study site
Salisbury, Maryland
Study site
San Antonio, Texas
Study site
Santa Rosa, California
Study site
Takoma Park, Maryland
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Troy, Michigan
Study site
Urbana, Illinois
Study site
Van Nuys, California
Study site
West Des Moines, Iowa
Study site
West Orange, New Jersey
Study site
Winston-Salem, North Carolina
Study site
Wyomissing, Pennsylvania
About this study
The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.
- Conditions
- Bradycardia
- Keywords
- MR conditional
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Performance | Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months. | |
| Multiple MRI Scan Characterization | Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Related Complication Rate
Measured: 5 years
Lead Related Complication Rate
Measured: 5 years
Secondary outcomes (4)
Assess change in pacing thresholds after multiple MRI scans
Measured: 5 years
Summarize MRI system and scan conditions
Measured: 5 years
Pacing system related events
Measured: 5 years
Characterize lead impedance
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 posted18 Feb 2011 (estimated)
- Study start8 Feb 2011
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies 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
- 2,483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299675
- Sponsor's protocol ID
- SureScan PAS
- Status last verified
- Apr 2018
- First submitted
- 16 Feb 2011
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Williamson BD, Gohn DC, Ramza BM, Singh B, Zhong Y, Li S, Shanahan L; SureScan Post-Approval Study Investigators. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC Clin Electrophysiol. 2017 Nov;3(11):1231-1239. doi: 10.1016/j.jacep.2017.05.011. Epub 2017 Sep 13.
PubMed 29759618
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SureScan Post-Approval Study
- ClinicalTrials.gov ID
- NCT01299675
- Acronym / sponsor ID
- SureScan PAS
- Conditions
- Bradycardia
- Keywords
- MR conditional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,483 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2011 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 18 Feb 2011 (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 Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Performance | – | –Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months. |
| Multiple MRI Scan Characterization | – | –Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Key inclusion criteria (3 listed)
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
- Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication
Key exclusion criteria (3 listed)
- Subject who is, or will be inaccessible for follow-up
- Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
- Subject 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
MRI Related Complication Rate
Time frame: 5 years
Lead Related Complication Rate
Time frame: 5 years
4 secondary outcomes
Assess change in pacing thresholds after multiple MRI scans
Time frame: 5 years
Summarize MRI system and scan conditions
Time frame: 5 years
Pacing system related events
Time frame: 5 years
Characterize lead impedance
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 27 Apr 2018.
- Derived from this study: PubMed 29759618Williamson BD, Gohn DC, Ramza BM, Singh B, Zhong Y, Li S, Shanahan L; SureScan Post-Approval Study Investigators. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC Clin Electrophysiol. 2017 Nov;3(11):1231-1239. doi: 10.1016/j.jacep.2017.05.011. Epub 2017 Sep 13.
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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.
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medtronic at 61 sites in 2 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada. 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?
MRI Related Complication Rate (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT01299675, which also lists 1 linked publication.
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 Apr 2018.