Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)

Acutus Medical

Status: Completed

Conditions: Supraventricular Tachycardia

Treatments: Device: Dipole Density Mapping with AcQMap followed by ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02469623

CL-SVT-001 (Other Identifier)

CL-SVT-006 (Other Identifier)

CL-SVT-004 (Other Identifier)

CL-SVT-002 (Other Grant/Funding Number)

CL-SVT-008 (Other Identifier)

CL-SVT-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Dipole Density Mapping

Experimental group

Treatment:

Device: Dipole Density Mapping with AcQMap followed by ablation