Dipole Density Mapping in Supraventricular Tachycardia

Overview

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

Full Title of Study: “Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 22, 2017

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.

Interventions

  • Device: Dipole Density Mapping with AcQMap followed by ablation

Arms, Groups and Cohorts

  • Experimental: Dipole Density Mapping

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Acutus Medical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Petr Neuzil, MD, Principal Investigator, Nemocnice Na Homolce

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