Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System

Atrial Fibrillation Clinical Trial

— STAR  

Official title:

Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System (STAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103945
• Other study ID #: CLIN-022
• Status: Completed
• Phase: N/A
• First received: March 26, 2017
• Last updated: November 23, 2017
• Start date: April 1, 2017
• Est. completion date: November 23, 2017

Study information

• Verified date: November 2017
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study evaluates peri-procedural results of the Niobe™ Remote Magnetic Navigation (RMN) ES system using the contact detection system (CDS) in patients undergoing standard of care radiofrequency ablation of cardiac arrhythmias.

The objective of this observational study is to confirm system performance of the CDS and that it does not alter pacing, electrocardiograms, or mapping during RF ablation procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 23, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with a clinical indication for RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system

• patients referred to one of the participating ablation centers

• written informed consent

Exclusion Criteria:

• presence of a atrial thrombus or left atrial appendage (LAA) thrombus seen on (contrast) echocardiography or MRI

• contra-indication for general anesthesia

• age below 18 years

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Intervention

Device:
• CDS box connection of the Niobe™ Remote Magnetic Navigation System
For all subjects included in the study, the ablation procedure will be started per standard of care. First mapping, pacing and electrocardiograms of the right atrium will be evaluated without the CDS box connected. Second the CDS box will be connected to the catheter and mapping, pacing and electrocardiograms will be recorded again. Next, ablation will be conducted per standard of care.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mapping quality	Physician's and technician's subjective score of the quality of mapping the right atrium without CDS box connected and with CDS box connected	One day - during ablation procedure
Primary	Pacing thresholds	Pacing thresholds of three separate areas of the right atrium without CDS box connected and pacing thresholds of the same three areas with CDS box connected	One day - during ablation procedure
Primary	Pacing capture	Pacing capture of three separate areas of the right atrium without CDS box connected and pacing capture of the same three areas with CDS box connected	One day - during ablation procedure
Primary	Electrocardiograms	Difference between and disturbance of the intracardiac electrocardiograms without the CDS box connected versus with the CDS box connected, evaluated by two independent and blinded electrophysiologists	10 months - ECGs will be evaluated after inclusion is completed
Secondary	Number of procedure related major adverse events, attributed to the CDS system	Major adverse events: death, acute myocardial infarction (AMI) or coronary artery damage, major bleeding - type III and V, abdominal bleeding, tamponade > 80cm3, late tamponade, ischemic cerebral event	30 days
Secondary	Number of procedure related minor adverse events, attributed to the CDS system	Minor adverse events: post procedural precordial pain, phrenic nerve injury, minor bleeding - type II	30 days
Secondary	Number of acute procedure succes	Number of procedures with successful electrical isolation of ablated area	1 day - during ablation procedure