Ventricular TachycardiaTPDNCT03402126
Tachy Prediction Download Study
An observational study of Ventricular Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 2 countries.
Trial summary
The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- TPD RAMWare
- How many people
- 138 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 12 Jan 2018to 26 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
Who may be able to join
- Subject is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:
- Secondary Prevention or,
- Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF
- Subject is ≥ 18 years old
- Subject has previously documented history of VT/VF
- Subject must be willing and able to use Medtronic CareLink network monitoring system
- Subject provides signed and dated authorization and/or consent per institution and local requirements
- Subject is willing and able to comply with the protocol
Who cannot join
- Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF
- Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- Subject has chronic AF
- Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
- Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
- Subject has active electronic medical device other than an ICD
Show all 11Show fewer
- Subject requires more than 25% atrial or ventricular pacing
- Subject has medical conditions that would limit study participation (per investigator judgment)
- Subject has projected life expectancy of less than 1 year
- Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study)
- Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Carolinas Medical Center
Charlotte, North Carolina, 28203
Mount Carmel East
Columbus, Ohio, 43213
Iowa Heart Center
Des Moines, Iowa, 50266
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111
Bryan Heart
Lincoln, Nebraska, 68506
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, 37203
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
Cape Fear Heart Associates
Wilmington, North Carolina, 28401
About this study
The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.
Read the detailed description
The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
- Conditions
- Ventricular Tachycardia
- Being tested
- TPD RAMWare
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPD RAMWareOther
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
| Study group | Role | What they receive |
|---|---|---|
| TPD RAMWare Download | Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data. Receives: Other: TPD RAMWare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start12 Jan 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
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 Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Brown, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402126
- Sponsor's protocol ID
- TPD Study
- Acronym
- TPD
- Status last verified
- Nov 2021
- First submitted
- 18 Dec 2017
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tachy Prediction Download Study
- ClinicalTrials.gov ID
- NCT03402126
- Acronym / sponsor ID
- TPD / TPD Study
- Conditions
- Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 16 Nov 2021
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 the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.
Detailed description
The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPD RAMWare Download | – | Other: TPD RAMWareSubjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
Key inclusion criteria (8 listed)
- Subject is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:
- Subject is ≥ 18 years old
- Subject has previously documented history of VT/VF
- Subject must be willing and able to use Medtronic CareLink network monitoring system
- Subject provides signed and dated authorization and/or consent per institution and local requirements
Key exclusion criteria (11 listed)
- Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF
- Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- Subject has chronic AF
- Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
- Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
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 |
|---|---|---|
| TPD RAMWareTPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use | Other | TPD RAMWare Download |
Primary outcome
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
Time frame: 1 year
This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Mark Brown study director
Medtronic
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 16 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 8 inclusion and 11 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 16 Nov 2021. 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, Hong Kong. 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 16 Nov 2021). 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?
Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes (time frame: 1 year). 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 16 Nov 2021.