Dipole Density Mapping in Supraventricular Tachycardia

Supraventricular Tachycardia Clinical Trial

— DDRAMATIC-SVT  

Official title:

Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469623
• Other study ID #: CL-SVT-005
• Secondary ID: CL-SVT-002CL-SVT
• Status: Completed
• Phase: N/A
• Start date: September 6, 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: August 2019
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT01875614
• NCT01914549
• NCT01921660
• NCT02469636
• NCT02469649

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Device:
• Dipole Density Mapping with AcQMap followed by ablation

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan AV Cardiologie	Bruges
Canada	Southlake Regional Health Center	Newmarket	Ontario
Chile	Pontificia Universidad Catolica de Chile	Santiago
Czechia	Na Homolce Hospital	Prague
Germany	Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf	Hamburg
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Barts Health NHS Trust	Whitechapel

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Countries where clinical trial is conducted

Belgium,  Canada,  Chile,  Czechia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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