Cardiac ArrhythmiasTRUE-HDNCT02698670
Prospective Registry on User Experience With The Mapping System For Ablation Procedures
An observational study of Cardiac Arrhythmias, run by Boston Scientific Corporation at 28 sites in 8 countries.
Trial summary
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Rhythmia mapping system and IntellaMap Orion mapping catheter
- Type of treatment
- Medical device
- How many people
- 577 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 25 May 2016to May 2017
- How long will I take part?
- 1 Month
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion
Who may be able to join
- Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Subjects requiring de novo ablation of atrial fibrillation;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility*;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
- Unrecovered/unresolved Adverse Events from any previous invasive procedure;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United States18 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
University of Chicago Hospital
Chicago, Illinois, 60637
Riverside Methodist - Ohio Health
Cincinnati, Ohio, 43214
Good Samaritan Hospital
Cincinnati, Ohio, 45220
University of Kansas Hospital
Kansas City, Kansas, 66160
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Baptist Memorial Hosptial
Memphis, Tennessee, 38138
Maimonidies Hospital
New York, New York, 11219
Heart Rhythm Institute
Oklahoma City, Oklahoma, 73104
Hoag Memorial Hospital
Orange, California, 92868
Oregon Health Sciences University
Portland, Oregon, 97239
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Virginia Mason Medical Center
Seattle, Washington, 98101
Torrance Memorial Medical Center
Torrance, California, 90505
Trinity Mother Francis
Tyler, Texas, 75701
France2 sites
CHU de Bordeaux
Pessac, 33604
Centre Hôpital Universitaire Rangueil
Toulouse, 31059
Germany2 sites
Universitaetsklinik Eppendorf
Hamburg, 20251
Herzzentrum Universität Leipzig
Leipzig
United Kingdom2 sites
Harefield Hospital
London, SW3 6NP
The Brompton Hospital
London, SW3 6NP
About this study
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
Read the detailed description
The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system.
The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Rhythmia mapping system, IntellaMap Orion mapping catheter
- Keywords
- Cardiac Arrhythmias, Cardiovascular Disease, Radiofrequency Ablation, Cardiac Mapping
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmia mapping systemDevice
A 3-D Cardiac Mapping system
IntellaMap Orion mapping catheterDevice
A diagnostic basket mapping catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
Primary endpoint is the acute procedural success for the primary arrhythmia in the whole cohort of ablation procedures. A procedure will be defined successful if all the following conditions will occur during the case: 1) ability to map, 2) completion of the necessary ablation applications, 3) primary arrhythmia termination (when applicable), and 4) validation of ablation through appropriate technique(s).
Measured: At the end of the index procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start25 May 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 577 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, Principal investigator, Gerhard Hindricks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698670
- Sponsor's protocol ID
- 91118280
- Acronym
- TRUE-HD
- Status last verified
- Jun 2017
- First submitted
- 24 Feb 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry on User Experience With The Mapping System For Ablation Procedures
- ClinicalTrials.gov ID
- NCT02698670
- Acronym / sponsor ID
- TRUE-HD / 91118280
- Conditions
- Cardiac Arrhythmias
- Keywords
- Cardiac Arrhythmias, Cardiovascular Disease, Radiofrequency Ablation, Cardiac Mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Mar 2016 (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.
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
Detailed description
The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system.
The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion
Key inclusion criteria (4 listed)
- Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.
Key exclusion criteria (6 listed)
- Subjects requiring de novo ablation of atrial fibrillation;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility*;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
- Unrecovered/unresolved Adverse Events from any previous invasive procedure;
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 |
|---|---|---|
| Rhythmia mapping systemA 3-D Cardiac Mapping system | Device | – |
| IntellaMap Orion mapping catheterA diagnostic basket mapping catheter | Device | – |
Primary outcome
Acute Procedural Success
Time frame: At the end of the index procedure (Day 0)
Primary endpoint is the acute procedural success for the primary arrhythmia in the whole cohort of ablation procedures. A procedure will be defined successful if all the following conditions will occur during the case: 1) ability to map, 2) completion of the necessary ablation applications, 3) primary arrhythmia termination (when applicable), and 4) validation of ablation through appropriate technique(s).
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 25 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Gerhard Hindricks principal investigator
Gerhard Hindricks
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Boston Scientific Corporation at 28 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 4 inclusion and 6 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Germany, United Kingdom, Australia 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?
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?
Acute Procedural Success (time frame: At the end of the index procedure (Day 0)). 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 25 Jan 2018.