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Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)

Primary Purpose

Supraventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dipole Density Mapping with AcQMap followed by ablation
Sponsored by
Acutus Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Supraventricular Tachycardia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AZ Sint-Jan AV Cardiologie
  • Southlake Regional Health Center
  • Pontificia Universidad Catolica de Chile
  • Na Homolce Hospital
  • Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
  • Papworth Hospital NHS Foundation Trust
  • Liverpool Heart and Chest Hospital
  • Barts Health NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dipole Density Mapping

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2015
Last Updated
August 15, 2019
Sponsor
Acutus Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02469623
Brief Title
Dipole Density Mapping in Supraventricular Tachycardia
Acronym
DDRAMATIC-SVT
Official Title
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2014 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acutus Medical

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dipole Density Mapping
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dipole Density Mapping with AcQMap followed by ablation
Primary Outcome Measure Information:
Title
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Description
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.
Time Frame
7 days
Title
The Number of Patients for Which Activation Maps Can be Created
Description
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD
Organizational Affiliation
Nemocnice Na Homolce
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan AV Cardiologie
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
ZIP/Postal Code
Región Metropolitana
Country
Chile
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
D - 20246
Country
Germany
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB23
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
Whitechapel
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30895945
Citation
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.
Results Reference
derived

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Dipole Density Mapping in Supraventricular Tachycardia

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