Heart FailureNCT02470312
MediGuide Registry
An observational study of Heart Failure and Cardiac Arrhythmia, run by Abbott Medical Devices at 16 sites in 8 countries.
Trial summary
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Cardiac Arrhythmia
- What is being tested?
- CRT implantation, MediGuide and EP
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 578 participants
- Where
- 16 sitesin 8 countries
- Study dates
- 18 Aug 2015to 28 Feb 2018
- How long will I take part?
- 5 Days
- 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: CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.
Who may be able to join
- Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
Who cannot join
- None
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
United States6 sites
Athens Regional Medical Center
Athens, Georgia, 30606
North Texas Heart Center
Dallas, Texas, 75231
Memorial Hermann Southwest Hospital
Houston, Texas
Gwinnett Medical Center
Lawrenceville, Georgia, 30046
Central Baptist Hospital
Lexington, Kentucky, 40503
John C Lincoln North Mountain Hospital
Phoenix, Arizona, 85020
Germany4 sites
Klinikum Inglostadt
Ingolstadt
Herzzentrum Leipzig
Leipzig
Deutsches Herzzentrum München des Freistaates Bayern
München
Kliniken Villingen-Schwenningen
Villingen-Schwenningen
About this study
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
Read the detailed description
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:
- The amount of fluoroscopy time and the radiation exposure
- Total procedure time
- Peri-procedural clinical event rate
Additionally, this study will address the following
- Identification of procedural challenges which may aid in developing future MediGuide tools
- Evaluation of newly available MediGuide tools during the study
- Correlation between MediGuide operator experience and the radiation exposure amount and time
- Conditions
- Heart Failure, Cardiac Arrhythmia
- Being tested
- CRT implantation, MediGuide, EP
- Keywords
- utility of MediGuide system, CRT, EP
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT implantationProcedure or surgery
It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment
MediGuideDevice
EPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CRT | Patients who are undergoing CRT implantation utilizing MediGuide system and tools Receives: Procedure: CRT implantation; Device: MediGuide | |
| EP | Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools Receives: Device: MediGuide; Procedure: EP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Fluoroscopy Time
Amount of fluoroscopy time during CRT implant or EP procedure
Measured: Expected time frame is day 1 of the study
Periprocedural Adverse Event
Adverse event until patients are discharged from the site center
Measured: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start18 Aug 2015
- Primary completion10 Feb 2017
- Study completion28 Feb 2018
Why it stopped: Existing trials demonstrate reduction in fluoroscopy with MediGuide
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 578 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470312
- Sponsor's protocol ID
- 10051
- Status last verified
- Jan 2019
- First submitted
- 28 Apr 2015
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MediGuide Registry
- ClinicalTrials.gov ID
- NCT02470312
- Acronym / sponsor ID
- 10051
- Conditions
- Heart Failure, Cardiac Arrhythmia
- Keywords
- utility of MediGuide system, CRT, EP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Existing trials demonstrate reduction in fluoroscopy with MediGuide
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 11 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
Detailed description
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:
- The amount of fluoroscopy time and the radiation exposure
- Total procedure time
- Peri-procedural clinical event rate
Additionally, this study will address the following
- Identification of procedural challenges which may aid in developing future MediGuide tools
- Evaluation of newly available MediGuide tools during the study
- Correlation between MediGuide operator experience and the radiation exposure amount and time
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT | – | Procedure: CRT implantation, Device: MediGuidePatients who are undergoing CRT implantation utilizing MediGuide system and tools |
| EP | – | Device: MediGuide, Procedure: EPPatients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CRT Group All patients from participating sites who are indicated for a CRT-D/P device implant, including an upgrade with a new left ventricular (LV) lead implant and are implanted with St. Jude Medical pulse generators and willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted with non-St. Jude Medical leads EP Group All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or ventricular tachycardia (VT) ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and willing to provide written Informed Consent can be enrolled in this study.
Key inclusion criteria (1 listed)
- Anybody coming for CRT or EP procedure utilizing MediGuide system and tools
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT implantationIt is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment | Procedure or surgery | CRT |
| MediGuide | Device | CRT, EP |
| EP | Procedure or surgery | EP |
Primary outcome
Amount of Fluoroscopy Time
Time frame: Expected time frame is day 1 of the study
Amount of fluoroscopy time during CRT implant or EP procedure
Periprocedural Adverse Event
Time frame: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days
Adverse event until patients are discharged from the site center
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristin Ruffner, PhD study director
Abbott
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Arrhythmia, run by Abbott Medical Devices at 16 sites in 8 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Australia, Austria, Canada and 3 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 11 Jan 2019). 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?
Amount of Fluoroscopy Time (time frame: Expected time frame is day 1 of the study). 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?
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 4 Feb 2019.