Atrial FibrillationSTARNCT03103945
Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System
An observational study of Atrial Fibrillation and Catheter Ablation, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation
- What is being tested?
- CDS box connection of the Niobe™ Remote Magnetic Navigation System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2017to 23 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive participant sampling of patients who will receive RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Being tested
- CDS box connection of the Niobe™ Remote Magnetic Navigation System
- Keywords
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac, Cardiac Diseases, Electrophysiologic Techniques, Cardiac, Electrophysiology, Remote Magnetic Navigation, Contact Detection System
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDS box connection of the Niobe™ Remote Magnetic Navigation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiac arrhythmias undergoing RF ablation | Patients with cardiac arrhythmias will be undergoing RF ablation using the Niobe Remote Magnetic Navigation System with CDS as their standard of care. System performance data will only be collected during the RF ablation procedure. Outcome measures will be evaluated with the CDS connected and without the CDS connected within all patients. Receives: Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day - during ablation procedure
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
Measured: One day - during ablation procedure
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
Measured: One day - during ablation procedure
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
Measured: 10 months - ECGs will be evaluated after inclusion is completed
Secondary outcomes (3)
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
Measured: 30 days
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
Measured: 30 days
Number of acute procedure succes
Number of procedures with successful electrical isolation of ablated area
Measured: 1 day - during ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Apr 2017
- Primary completion8 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Marie Noten, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103945
- Sponsor's protocol ID
- CLIN-022
- Acronym
- STAR
- Status last verified
- Nov 2017
- First submitted
- 26 Mar 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03103945
- Acronym / sponsor ID
- STAR / CLIN-022
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Keywords
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac, Cardiac Diseases, Electrophysiologic Techniques, Cardiac, Electrophysiology, Remote Magnetic Navigation, Contact Detection System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiac arrhythmias undergoing RF ablation | – | Device: CDS box connection of the Niobe™ Remote Magnetic Navigation SystemPatients with cardiac arrhythmias will be undergoing RF ablation using the Niobe Remote Magnetic Navigation System with CDS as their standard of care. System performance data will only be collected during the RF ablation procedure. Outcome measures will be evaluated with the CDS connected and without the CDS connected within all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive participant sampling of patients who will receive RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDS box connection of the Niobe™ Remote Magnetic Navigation SystemFor 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. | Device | Patients with cardiac arrhythmias undergoing RF ablation |
Primary outcome
Mapping quality
Time frame: One day - during ablation procedure
Physician's and technician's subjective score of the quality of mapping the right atrium without CDS box connected and with CDS box connected
Pacing thresholds
Time frame: One day - during ablation procedure
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
Pacing capture
Time frame: One day - during ablation procedure
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
Electrocardiograms
Time frame: 10 months - ECGs will be evaluated after inclusion is completed
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
3 secondary outcomes
Number of procedure related major adverse events, attributed to the CDS system
Time frame: 30 days
Number of procedure related minor adverse events, attributed to the CDS system
Time frame: 30 days
Number of acute procedure succes
Time frame: 1 day - during ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Catheter Ablation, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mapping quality (time frame: One day - during ablation procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.