Clinical trial NCT02469623: Dipole Density Mapping in Supraventricular Tachycardia
Official title: Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraventricular Tachycardia
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
timeFrame: 7 days
measure: The Number of Patients for Which Activation Maps Can be Created
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: AZ Sint-Jan AV Cardiologie
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Hamburg
country: Germany
facility: Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Whitechapel
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Nemocnice Na Homolce
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.