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Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469623
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

Brief Summary:
Use of dipole density mapping to identify activation in complex supraventricular tachycardias.

Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia Device: Dipole Density Mapping with AcQMap followed by ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Actual Study Start Date : September 6, 2014
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

Arm Intervention/treatment
Experimental: Dipole Density Mapping Device: Dipole Density Mapping with AcQMap followed by ablation



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Be aged 18-75 years
  2. Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
  3. Be able and willing to give informed consent

Exclusion Criteria

  1. 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)
  2. MI within the prior two (2) months
  3. Cardiac surgery within the prior three (3) months
  4. Intracardiac thrombus
  5. Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
  6. Cerebral ischemic event (including TIA) in the prior six (6) months
  7. Pregnant or nursing
  8. Currently enrolled in another clinical investigation
  9. Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
  10. Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
  11. Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
  12. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469623


Locations
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Belgium
AZ Sint-Jan AV Cardiologie
Bruges, Belgium, 8000
Canada, Ontario
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile, Región Metropolitana
Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
Germany
Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, D - 20246
United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB23
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
Barts Health NHS Trust
Whitechapel, United Kingdom, E1 1BB
Sponsors and Collaborators
Acutus Medical
Investigators
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Principal Investigator: Petr Neuzil, MD Nemocnice Na Homolce
  Study Documents (Full-Text)

Documents provided by Acutus Medical:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT02469623    
Obsolete Identifiers: NCT01875614, NCT01914549, NCT01921660, NCT02469636, NCT02469649
Other Study ID Numbers: CL-SVT-005
CL-SVT-002 ( Other Grant/Funding Number: Acutus Medical )
CL-SVT-001 ( Other Identifier: Acutus Medical )
CL-SVT-004 ( Other Identifier: Acutus Medical )
CL-SVT-006 ( Other Identifier: Acutus Medical )
CL-SVT-008 ( Other Identifier: Acutus Medical )
First Posted: June 11, 2015    Key Record Dates
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes