Persistent Atrial FibrillationFIND CANNCT03033641
FIND CAN Trial: "CF-172"
A study testing Ablation procedure in people with Persistent Atrial Fibrillation, run by Biosense Webster, Inc..
Trial summary
The purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the termination of atrial fibrillation to either Normal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Ablation procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2016to 30 Aug 2017
- 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
- Subjects must meet the following inclusion criteria:
- Age > 18 years.
- Patients who have 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).
- 3.1. Drug-refractory atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)
Who cannot join
- Subject who meet any of the following exclusion criteria are not eligible for enrollment.
- Paroxysmal Atrial Fibrillation
- Continuous AF > 12 months (1 Year) (Longstanding Persistent AF) 2.1. Subjects previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the ability to maintain Normal Sinus Rhythm for >30 days after cardioversion and have not been in AF greater than 1 year at the time of the procedure remain eligible for inclusion.
- Previous ablation procedure for AF (previous ablation for the treatment of Flutter is acceptable)
- Patients with a left atrial size >55 mm (echocardiography, parasternal long axis view).
- Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.
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- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Atrial arrhythmia patients with 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, 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 a study evaluating another device or drug.
- A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Patients with a prosthetic mitral valve or any mechanical valve
- Any cardiac surgery within the past 60 days (2 months) (includes PCI) (bypass within the past year)
- Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- Prior ICD or pacemaker implanted
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access.
- Subject has a contra-indication to any of the devices used in the study per the IFU
- Women of child bearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial.
About this study
Official title: Feasibility of the CARTOFINDER™ 4D LAT Algorithm to Identify Ablation Target in Subjects With Atrial Fibrillation (FIND CAN Trial: "CF-172")
The purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Ablation procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation procedureDevice
Also called CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)
All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.
| Study group | Role | What they receive |
|---|---|---|
| Ablation procedure | Experimental | Not described Receives: Device: Ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate mapping characteristics
Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm
Measured: Intraoperative
Evaluate acute safety of freedom from procedure-related primary adverse events
Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure
Measured: Within 7 days
Secondary outcomes (1)
Evaluate atrial fibrillation (AF) termination
Evaluate the AF termination to Normal Sinus Rhythm (NSR) or an Atrial Tachycardia (AT) after CARTOFINDER™ Guided Ablation (CFGA) of identified ablation target and after PVI
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start5 Dec 2016
- Primary completion4 May 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033641
- Sponsor's protocol ID
- BWI CF-172
- Acronym
- FIND CAN
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the CARTOFINDER™ 4D LAT Algorithm to Identify Ablation Target in Subjects With Atrial Fibrillation (FIND CAN Trial: "CF-172")
- ClinicalTrials.gov ID
- NCT03033641
- Acronym / sponsor ID
- FIND CAN / BWI CF-172
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 27 Jan 2017 (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 purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation procedure | Experimental | Device: Ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years.
- Patients who have 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).
- 3.1. Drug-refractory atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)
Key exclusion criteria (19 listed)
- Subject who meet any of the following exclusion criteria are not eligible for enrollment.
- Paroxysmal Atrial Fibrillation
- Continuous AF > 12 months (1 Year) (Longstanding Persistent AF) 2.1. Subjects previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the ability to maintain Normal Sinus Rhythm for >30 days after cardioversion and have not been in AF greater than 1 year at the time of the procedure remain eligible for inclusion.
- Previous ablation procedure for AF (previous ablation for the treatment of Flutter is acceptable)
- Patients with a 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 |
|---|---|---|
| Ablation procedureAlso: CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study. | Device | Ablation procedure |
Primary outcome
Evaluate mapping characteristics
Time frame: Intraoperative
Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm
Evaluate acute safety of freedom from procedure-related primary adverse events
Time frame: Within 7 days
Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure
1 secondary outcome
Evaluate atrial fibrillation (AF) termination
Time frame: Perioperative
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 3 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation procedure in people with Persistent Atrial Fibrillation, run by Biosense Webster, Inc..
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 6 inclusion and 19 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate mapping characteristics (time frame: Intraoperative). 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 3 Feb 2025.