Supraventricular TachycardiaNCT00979303
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
A study testing Intracardiac echocardiography and 3D navigational system in people with Supraventricular Tachycardia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Intracardiac echocardiography and 3D navigational system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2009to 28 May 2010
- Phase
- Interventional
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age >/=8
- Weight >/=25kg
- Structurally normal heart (no major cardiac defects)
- History of SVT
- No prior history of cardiac surgery or ablation
Who cannot join
- Congenital Heart Disease
- Prior history of cardiac surgery or ablation
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.
Read the detailed description
The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Intracardiac echocardiography and 3D navigational system
- Keywords
- Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac echocardiography and 3D navigational systemDevice
Also called AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational system
Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control Patients - Undergo ablation procedures with radiation/fluoroscopy only |
| Study Group | Experimental | Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation. Receives: Device: Intracardiac echocardiography and 3D navigational system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fluoroscopy Time
Total fluoroscopy time in minutes
Measured: During the Ablation procedure
Secondary outcomes (1)
Total Radiation Exposure
Total radiation exposure measured in mGy
Measured: During Ablation Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study start9 Jan 2009
- Primary completion28 Sep 2009
- Study completion28 May 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Yumi Miyake, Boston Children's Hospital
- Investigators
- Christina Y. Miyake, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979303
- Sponsor's protocol ID
- 08110505
- Status last verified
- Feb 2018
- First submitted
- 17 Sep 2009
- Last updated
- 8 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Miyake CY, Mah DY, Atallah J, Oikle HP, Melgar ML, Alexander ME, Berul CI, Cecchin F, Walsh EP, Triedman JK. Nonfluoroscopic imaging systems reduce radiation exposure in children undergoing ablation of supraventricular tachycardia. Heart Rhythm. 2011 Apr;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15.
PubMed 21167315
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT00979303
- Acronym / sponsor ID
- 08110505
- Conditions
- Supraventricular Tachycardia
- Keywords
- Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 9 Jan 2009 (actual)
- Primary completion
- 28 Sep 2009 (actual)
- Study completion
- 28 May 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 8 Mar 2018
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 determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.
Detailed description
The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control Patients - Undergo ablation procedures with radiation/fluoroscopy only |
| Study Group | Experimental | Device: Intracardiac echocardiography and 3D navigational systemStudy Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age >/=8
- Weight >/=25kg
- Structurally normal heart (no major cardiac defects)
- History of SVT
- No prior history of cardiac surgery or ablation
Key exclusion criteria (2 listed)
- Congenital Heart Disease
- Prior history of cardiac surgery or ablation
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 |
|---|---|---|
| Intracardiac echocardiography and 3D navigational systemAlso: AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational systemPatients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure. | Device | Study Group |
Primary outcome
Total Fluoroscopy Time
Time frame: During the Ablation procedure
Total fluoroscopy time in minutes
1 secondary outcome
Total Radiation Exposure
Time frame: During Ablation Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21167315Miyake CY, Mah DY, Atallah J, Oikle HP, Melgar ML, Alexander ME, Berul CI, Cecchin F, Walsh EP, Triedman JK. Nonfluoroscopic imaging systems reduce radiation exposure in children undergoing ablation of supraventricular tachycardia. Heart Rhythm. 2011 Apr;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15.
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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.
Christina Y. Miyake, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac echocardiography and 3D navigational system in people with Supraventricular Tachycardia, run by Boston Children's Hospital at 1 site in United States.
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 5 inclusion and 2 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 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 8 Mar 2018). 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?
Total Fluoroscopy Time (time frame: During the Ablation procedure). 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 NCT00979303, 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 8 Mar 2018; AzTrials last refreshed its copy on 28 Oct 2026.