ArrhythmiasNCT02565069
Identification for the Treatment of Complex Arrhythmias
A study testing CartoFinder™ Device with CARTO® 3 System V5 Navigation in people with Arrhythmias, run by Biosense Webster, Inc. at 4 sites in 2 countries.
Trial summary
The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- CartoFinder™ Device with CARTO® 3 System V5 Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jul 2015to 24 Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years.
- Signed the Patient Informed Consent Form (ICF)
- Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
- Persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).
- Drug-resistant Atrial Fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
- Persistent AF despite prior conventional ablation.
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- Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
- In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Who cannot join
- Paroxysmal Atrial Fibrillation
- Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
- Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) > 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure.
- A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease.
- Left atrial size >55 mm (echocardiography, parasternal long axis view).
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
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- Structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.
- History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor), significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.
- Enrollment in an experimental study evaluating another device or drug under investigation.
- Prosthetic valve
- Presence of intramural thrombus, tumor or other abnormality / condition that precludes vascular access, catheter introduction or manipulation.
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Onze-Lieve-Vrouwziekenhuis (OLV) Hospital
Aalst, Moorselbaan, 164 - 9300
Algemeen Ziekenhuis (AZ) Sint Jan Brugge
Ruddershove, Brugge, 10 - 8000
Universitair Ziekenhuis A ntwerpen (UZA)
Wilrijkstraat, Edegem, 10 - 2650
Czechia1 site
České Budějovice Hospital
České Budějovice, Němcové, 585/54 - 370 01
About this study
Official title: Identification for the Treatment of Complex Arrhythmias (CartoFinder™ Algorithm Trial: "CF163 EU")
The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
- Conditions
- Arrhythmias
- Being tested
- CartoFinder™ Device with CARTO® 3 System V5 Navigation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartoFinder™ Device with CARTO® 3 System V5 NavigationDevice
Ablation treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Use of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias Receives: Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify rate of slowing for the overall mean atrial fibrillation rate
Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm
Measured: Day 0 (procedure date)
Evaluate Freedom from procedure-related primary adverse events
Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure
Measured: 7 days
Secondary outcomes (5)
Evaluate procedural results
Proportion of subjects with focal impulses / Repetitive Activation Pattern (RAP)s and number of areas and locations of focal impulses / RAPs
Measured: Day 0 (procedure date)
Evaluate procedural results
Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation
Measured: Day 0 (procedure date)
Evaluate procedural results
Proportion of subjects with AF organization after CF guided ablation
Measured: Day 0 (procedure date)
Evaluate procedural results
Proportion of subjects with acute procedural success, i.e. subjects with spontaneous return to NSR or AF organization after CF guided ablation
Measured: Day 0 (procedure date)
Evaluate freedom from documented recurrence of atrial fibrillation
Evaluate freedom from documented recurrence of atrial fibrillation at 6 and 12 months post-procedure
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start1 Jul 2015
- Primary completion24 Jan 2017
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565069
- Sponsor's protocol ID
- FIND-EU - CF163
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification for the Treatment of Complex Arrhythmias (CartoFinder™ Algorithm Trial: "CF163 EU")
- ClinicalTrials.gov ID
- NCT02565069
- Acronym / sponsor ID
- FIND-EU - CF163
- Conditions
- Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: CartoFinder™ Device with CARTO® 3 System V5 NavigationUse of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Signed the Patient Informed Consent Form (ICF)
- Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
- Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
- In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
Key exclusion criteria (13 listed)
- Paroxysmal Atrial Fibrillation
- Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
- Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) > 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure.
- A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease.
- Left atrial size >55 mm (echocardiography, parasternal long axis view).
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 |
|---|---|---|
| CartoFinder™ Device with CARTO® 3 System V5 NavigationAblation treatment | Device | Treatment group |
Primary outcome
Identify rate of slowing for the overall mean atrial fibrillation rate
Time frame: Day 0 (procedure date)
Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm
Evaluate Freedom from procedure-related primary adverse events
Time frame: 7 days
Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure
5 secondary outcomes
Evaluate procedural results
Time frame: Day 0 (procedure date)
Evaluate procedural results
Time frame: Day 0 (procedure date)
Evaluate procedural results
Time frame: Day 0 (procedure date)
Evaluate procedural results
Time frame: Day 0 (procedure date)
Evaluate freedom from documented recurrence of atrial fibrillation
Time frame: 6 and 12 months
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 15 Jun 2026.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CartoFinder™ Device with CARTO® 3 System V5 Navigation in people with Arrhythmias, run by Biosense Webster, Inc. at 4 sites in 2 countries.
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 9 inclusion and 13 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Czechia. 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?
Identify rate of slowing for the overall mean atrial fibrillation rate (time frame: Day 0 (procedure date)). The study lists 2 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 15 Jun 2026.