N/A
N=85
Dipole Density Mapping in Supraventricular Tachycardia
Supraventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT02469623 ↗Enrolled (actual)
85
Serious AEs
11.8%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events — 71; 14; 85; 83 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dipole Density Mapping with AcQMap followed by ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acutus Medical
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events |
71; 14; 85; 83; 71; 85 | — |
| PRIMARY The Number of Patients for Which Activation Maps Can be Created |
83; 71 | — |
Summary
Use of dipole density mapping to identify activation in complex supraventricular tachycardias.
Eligibility Criteria
Inclusion Criteria
- Be aged 18-75 years
- Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
- Be able and willing to give informed consent
Exclusion Criteria
- 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)
- MI within the prior two (2) months
- Cardiac surgery within the prior three (3) months
- Intracardiac thrombus
- Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
- Cerebral ischemic event (including TIA) in the prior six (6) months
- Pregnant or nursing
- Currently enrolled in another clinical investigation
- Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
- Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
- Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
- 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.
Data sourced from ClinicalTrials.gov (NCT02469623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.