Dipole Density Mapping in Supraventricular Tachycardia

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.

• Dipole Density Mapping with AcQMap followed by ablation (Device)

Primary outcomes

• Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events [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 [1 day]: The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.

Sex: All, ages: 18 Years to 75 Years

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.

Participant flow

Outcome results

• Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events (Primary), Count of participants, Participants: Treated Subjects 71
• The Number of Patients for Which Activation Maps Can be Created (Primary), Number, participants: Subjects Scheduled for Ablation of an SVT 83

Adverse events

Time frame: Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 30895945

• Study Protocol and Statistical Analysis Plan (PDF, 2016-03-10)

• Petr Neuzil, MD, Principal investigator, Nemocnice Na Homolce