Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)

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.

Study Overview

• Status: Completed
• Conditions: Supraventricular Tachycardia
• Intervention / Treatment: Device: Dipole Density Mapping with AcQMap followed by ablation

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan AV Cardiologie
• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center
• Chile
  • Santiago, Chile, Región Metropolitana
    • Pontificia Universidad Católica de Chile
• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• Germany
  • Hamburg, Germany, D - 20246
    • Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
• United Kingdom
  • Cambridge, United Kingdom, CB23
    • Papworth Hospital NHS Foundation Trust
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital
  • Whitechapel, United Kingdom, E1 1BB
    • Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dipole Density Mapping	Device: Dipole Density Mapping with AcQMap followed by ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Principal Investigator: Petr Neuzil, MD, Nemocnice Na Homolce

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2014
• Primary Completion (Actual): May 22, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Supraventricular
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No