Supraventricular TachycardiaDDRAMATIC-SVTNCT02469623
Dipole Density Mapping in Supraventricular Tachycardia
A study testing Dipole Density Mapping with AcQMap followed by ablation in people with Supraventricular Tachycardia, run by Acutus Medical at 8 sites in 6 countries.
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?
- Dipole Density Mapping with AcQMap followed by ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 6 Sep 2014to 22 May 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18-75 years
- Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
- Be able and willing to give informed consent
Who cannot join
- Have any of the following:
- implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
- permanent pacemaker or ICD leads in the chamber being mapped
- hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
- Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
- MI within the prior two (2) months
Show all 17Show fewer
- Cardiac surgery within the prior three (3) months
- Intracardiac thrombus
- Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
- Cerebral ischemic event (including TIA) in the prior six (6) months
- Pregnant or nursing
- Currently enrolled in another clinical investigation
- Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
- Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
- Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
- Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)
- NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United Kingdom3 sites
Papworth Hospital NHS Foundation Trust
Cambridge, CB23
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Barts Health NHS Trust
Whitechapel, E1 1BB
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Región Metropolitana
Germany1 site
Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
Hamburg, D - 20246
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.
Read the detailed description
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:
NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, \& Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)
All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Dipole Density Mapping with AcQMap 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.
Dipole Density Mapping with AcQMap followed by ablationDevice
| Study group | Role | What they receive |
|---|---|---|
| Dipole Density Mapping | Experimental | Not described Receives: Device: Dipole Density Mapping with AcQMap followed by ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
Measured: 7 days
The Number of Patients for Which Activation Maps Can be Created
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start6 Sep 2014
- Primary completion22 May 2017
- Study completion22 May 2017
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.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, Principal investigator, Nemocnice Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469623
- Sponsor's protocol ID
- CL-SVT-005
- Other IDs
- CL-SVT-002, CL-SVT-001, CL-SVT-004, CL-SVT-006, CL-SVT-008
- Acronym
- DDRAMATIC-SVT
- Status last verified
- Aug 2019
- First submitted
- 8 Jun 2015
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grace A, Willems S, Meyer C, Verma A, Heck P, Zhu M, Shi X, Chou D, Dang L, Scharf C, Scharf G, Beatty G. High-resolution noncontact charge-density mapping of endocardial activation. JCI Insight. 2019 Mar 21;4(6):e126422. doi: 10.1172/jci.insight.126422. eCollection 2019 Mar 21.
PubMed 30895945
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 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
- NCT02469623
- Acronym / sponsor ID
- DDRAMATIC-SVT / CL-SVT-005
- Conditions
- Supraventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2014 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 18 Sep 2019
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.
Detailed description
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:
NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, \& Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)
All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
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: Dipole Density Mapping with AcQMap 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)
- Be aged 18-75 years
- Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
- Be able and willing to give informed consent
Key exclusion criteria (17 listed)
- Have any of the following:
- MI within the prior two (2) months
- Cardiac surgery within the prior three (3) months
- Intracardiac thrombus
- Clinically significant tricuspid and/or mitral 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 |
|---|---|---|
| Dipole Density Mapping with AcQMap followed by ablation | Device | Dipole Density Mapping |
Primary outcome
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Time frame: 7 days
Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
The Number of Patients for Which Activation Maps Can be Created
Time frame: 1 day
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30895945Grace A, Willems S, Meyer C, Verma A, Heck P, Zhu M, Shi X, Chou D, Dang L, Scharf C, Scharf G, Beatty G. High-resolution noncontact charge-density mapping of endocardial activation. JCI Insight. 2019 Mar 21;4(6):e126422. doi: 10.1172/jci.insight.126422. eCollection 2019 Mar 21.
- Individual participant dataSharing planned: Undecided
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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.
Petr Neuzil, MD principal investigator
Nemocnice Na Homolce
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dipole Density Mapping with AcQMap followed by ablation in people with Supraventricular Tachycardia, run by Acutus Medical at 8 sites in 6 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 3 inclusion and 17 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Belgium, Canada, Chile, Czechia and 1 more country. 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 18 Sep 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?
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events (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?
On the ClinicalTrials.gov record for NCT02469623, 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 18 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.