Cardiac ArrythmiasNCT07361445
Agilis RF TSP Early Feasibility Study
A study testing Transseptal procedure with Agilis RF TSP System. in people with Cardiac Arrythmias and Left Atrial Appendage Closure, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrythmias, Left Atrial Appendage Closure
- What is being tested?
- Transseptal procedure with Agilis RF TSP System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2026to 3 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Is able and willing to provide written informed consent prior to any clinical investigation-related procedure
- Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture
- Is at least 18 years of age
- Able and willing to comply with all study requirements
Who cannot join
- Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor
- Pregnant or nursing
- Known presence of intracardiac thrombus
- Known existing circumferential pericardial effusion (>2 mm)
- Previous interatrial septal patch or prosthetic atrial septal defect closure device
- Any previous thromboembolic event with in the last 6 months
Show all 13Show fewer
- Known or suspected left atrial myxoma
- Known or suspected myocardial infarction within the last two weeks
- Unstable angina
- Recent (within the last 3 months) cerebral vascular accident (CVA)
- Patients with an active infection
- Patients who do not tolerate anticoagulation therapy
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, 72401
- Recruiting
Research Medical Center
Kansas City, Missouri, 64132
- Recruiting
California Pacific Medical Center -Van Ness Campus
San Francisco, California, 94109
About this study
Official title: Agilis Radiofrequency Transseptal System Early Feasibility Study
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.
- Conditions
- Cardiac Arrythmias, Left Atrial Appendage Closure
- Being tested
- Transseptal procedure with Agilis RF TSP System.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal procedure with Agilis RF TSP System.Device
Radiofrequency wire will be used for the transseptal procedure.
| Study group | Role | What they receive |
|---|---|---|
| Transseptal Procedure | Experimental | Not described Receives: Device: Transseptal procedure with Agilis RF TSP System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Measured: During the procedure and periprocedurally
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.
The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start16 Feb 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion3 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361445
- Sponsor's protocol ID
- ABT-CIP-10601
- Status last verified
- May 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agilis Radiofrequency Transseptal System Early Feasibility Study
- ClinicalTrials.gov ID
- NCT07361445
- Acronym / sponsor ID
- ABT-CIP-10601
- Conditions
- Cardiac Arrythmias, Left Atrial Appendage Closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 23 Jan 2026 (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 study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transseptal Procedure | Experimental | Device: Transseptal procedure with Agilis RF TSP System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is able and willing to provide written informed consent prior to any clinical investigation-related procedure
- Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture
- Is at least 18 years of age
- Able and willing to comply with all study requirements
Key exclusion criteria (13 listed)
- Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor
- Pregnant or nursing
- Known presence of intracardiac thrombus
- Known existing circumferential pericardial effusion (>2 mm)
- Previous interatrial septal patch or prosthetic atrial septal defect closure device
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 |
|---|---|---|
| Transseptal procedure with Agilis RF TSP System.Radiofrequency wire will be used for the transseptal procedure. | Device | Transseptal Procedure |
Primary outcome
Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Time frame: During the procedure and periprocedurally
The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.
Time frame: Procedure
The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transseptal procedure with Agilis RF TSP System. in people with Cardiac Arrythmias and Left Atrial Appendage Closure, run by Abbott Medical Devices at 3 sites in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 2 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 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Gansemer, PhD (+1 952-715-2719, benjamin.gansemer@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge. (time frame: During the procedure and periprocedurally). 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 2 Jun 2026.