Supraventricular TachycardiaDDRAMATIC-SVTNCT01914575
Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia
A study testing Mapping with the Acutus Medical System followed by Ablation in people with Supraventricular Tachycardia, run by Acutus Medical at 1 site in Ireland.
Trial summary
Use of dipole density mapping to identify activation in complex supraventricular tachycardias Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Mapping with the Acutus Medical System followed by Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIreland
- Study dates
- 22 Jan 2014to 16 May 2016
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 75 years
- scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
- able and willing to give informed consent
Who cannot join
- implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
- myocardial infarction within the prior two months
- cardiac surgery within the prior three months
- intracardiac thrombus
- clinically significant tricuspid valve regurgitation or stenosis
- any cerebral ischemic event in the prior six months
- pregnant or nursing
- currently enrolled in any other clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Use of dipole density mapping to identify activation in complex supraventricular tachycardias
- Conditions
- Supraventricular Tachycardia
- Being tested
- Mapping with the Acutus Medical System followed by Ablation
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping with the Acutus Medical System followed by AblationDevice
| Study group | Role | What they receive |
|---|---|---|
| Dipole Density Mapping | Experimental | Not described Receives: Device: Mapping with the Acutus Medical System followed by Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with device-related complications
Measured: 7 days
The number of patients for which activation maps can be created
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start22 Jan 2014 (estimated)
- Primary completion16 May 2016
- Study completion16 May 2016
Why it stopped: Site never got up and running due to institutional issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Keane, MD, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914575
- Sponsor's protocol ID
- CL-SVT-003
- Acronym
- DDRAMATIC-SVT
- Status last verified
- Jan 2019
- First submitted
- 31 Jul 2013
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT01914575
- Acronym / sponsor ID
- DDRAMATIC-SVT / CL-SVT-003
- Conditions
- Supraventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site never got up and running due to institutional issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2014 (estimated)
- Primary completion
- 16 May 2016 (actual)
- Study completion
- 16 May 2016 (actual)
- First posted
- 2 Aug 2013 (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.
Use of dipole density mapping to identify activation in complex supraventricular tachycardias
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dipole Density Mapping | Experimental | Device: Mapping with the Acutus Medical System followed by Ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 to 75 years
- scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
- able and willing to give informed consent
Key exclusion criteria (8 listed)
- implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
- myocardial infarction within the prior two months
- cardiac surgery within the prior three months
- intracardiac thrombus
- clinically significant tricuspid valve regurgitation or stenosis
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 |
|---|---|---|
| Mapping with the Acutus Medical System followed by Ablation | Device | Dipole Density Mapping |
Primary outcome
The number of patients with device-related complications
Time frame: 7 days
The number of patients for which activation maps can be created
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- 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.
David Keane, MD principal investigator
St Vincent's University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapping with the Acutus Medical System followed by Ablation in people with Supraventricular Tachycardia, run by Acutus Medical at 1 site in Ireland.
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 8 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: withdrawn, as of the sponsor's last update on 31 Jan 2019. 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 Ireland. 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 was withdrawn before enrolling participants, so there are no results.
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?
The number of patients with device-related complications (time frame: 7 days). 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 31 Jan 2019.