Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02469636
Other study ID # CL-SVT-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2014
Est. completion date May 22, 2017

Study information

Verified date January 2019
Source Acutus Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 3
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. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation

2. able and willing to give informed consent

Exclusion Criteria:

1. implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .

2. myocardial infarction within the prior two months

3. cardiac surgery within the prior three months

4. intracardiac thrombus

5. clinically significant tricuspid valve regurgitation or stenosis

6. any cerebral ischemic event in the prior six months

7. pregnant or nursing

8. currently enrolled in any other clinical investigation

Study Design


Intervention

Device:
Dipole Density Mapping with AcQMap followed by ablation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Acutus Medical

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of device-and procedure-related adverse events 7 days
Primary The number of patients for which activation maps can be created 1 day
See also
  Status Clinical Trial Phase
Withdrawn NCT03153072 - Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia Phase 2
Completed NCT02469623 - Dipole Density Mapping in Supraventricular Tachycardia N/A
Completed NCT02469649 - Dipole Density Mapping of Supraventricular Tachycardia N/A
Completed NCT01921660 - Dipole Density Mapping in Right (and Left) SVT N/A
Completed NCT02952781 - Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial N/A
Completed NCT00390546 - Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia Phase 3
Completed NCT05531903 - High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia N/A
Recruiting NCT05022290 - Double-syringe vs Single-syringe Technique of Adenosine for Termination of Regular Narrow Complex Tachycardia N/A
Terminated NCT01216501 - Sevoflurane and Isoflurane for RF or Cryo Ablation in Children. N/A
Completed NCT00787800 - The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock Phase 4
Completed NCT04051541 - Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound N/A
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A
Completed NCT01426425 - Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia Phase 3
Not yet recruiting NCT03528616 - Management of Supraventricular Tachycardia of Children
Completed NCT01875614 - Dipole Density Mapping in Supraventricular Tachycardia N/A
Recruiting NCT01584154 - Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia Phase 4
Recruiting NCT05521451 - Clinical Cohort Study - TRUST
Enrolling by invitation NCT02031484 - Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial N/A
Not yet recruiting NCT02126631 - Sternal ECG Patch Comparison Trial N/A
Recruiting NCT04232371 - Treatment Study of AV Node Reentry Tachycardia N/A