Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01914497
Other study ID # CL-AFL-002
Secondary ID
Status Completed
Phase N/A
First received July 31, 2013
Last updated November 29, 2017
Start date October 2014
Est. completion date November 2014

Study information

Verified date November 2017
Source Acutus Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Be aged 18 to 75 years

2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)

3. Be able and willing to give informed consent

Exclusion Criteria:

1. Have any of the following:

1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.

2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure

3. Have had a myocardial infarction within the prior two months

4. Have had cardiac surgery within the prior three months

5. Have an intracardiac thrombus

6. Have clinically significant tricuspid valve regurgitation or stenosis

7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months

8. Be pregnant or nursing

9. Be currently enrolled in any other clinical investigation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acutus Medical System Mapping


Locations

Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Acutus Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of device-and procedure-related adverse events 7 days
Primary The number of patients in which offline construction of pre- and post-treatment activation maps can be completed 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Terminated NCT02317029 - Comparison of Oxygen Interventions and Defibrillator Efficiency N/A
Recruiting NCT01563848 - Cryoablation in Patients With Atrial Flutter Phase 2
Completed NCT01229254 - Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter Phase 2
Completed NCT00839657 - Clarification of Optimal Anticoagulation Through Genetics Phase 3
Completed NCT02065388 - Pharmacogenetic Dosing of Warfarin Phase 3
Completed NCT00232232 - Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT05468281 - RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
Completed NCT03627143 - Decreasing Hospital Admissions From the ED for AAFF N/A
Completed NCT02917538 - A Randomized Trial of Contact Force in Atrial Flutter Ablation N/A
Enrolling by invitation NCT05903313 - A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Recruiting NCT05755074 - Ablation of Typical Right Atrial Flutter N/A
Recruiting NCT05883631 - RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. N/A
Recruiting NCT03272620 - Atrial Fibrillation at the Viennese University Emergency Department N/A
Completed NCT02810938 - MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
Recruiting NCT02591875 - Atrial Flutter Ablation in a Real World Population N/A
Completed NCT02268799 - High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter N/A
Active, not recruiting NCT01976507 - Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism Phase 4
Completed NCT00232310 - Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr Phase 2