Agilis RF TSP Early Feasibility Study | NCT07361445

Studies
Agilis RF TSP Early Feasibility Study

NCT07361445

Sponsor

Abbott Medical Devices

Status

Recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cardiac Arrythmias
Left Atrial Appendage Closure

Interventions

Transseptal procedure with Agilis RF TSP System.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 16, 2026Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Aug 3, 2026Estimated

First Submitted Date

Jan 16, 2026

First Submission Date that Met QC Criteria

Jan 21, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2026

Last Update Posted Date

Jun 2, 2026Actual

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transseptal Procedure	Experimental		Device: Transseptal procedure with Agilis RF TSP System.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transseptal procedure with Agilis RF TSP System.	Device	Radiofrequency wire will be used for the transseptal procedure.	Transseptal Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ben Gansemer, PhD	Contact	+1 952-715-2719		benjamin.gansemer@abbott.com
Amber Miller, PhD	Contact	612-413-7236		amber.miller@abbott.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arrhythmia Research Group (St. Bernards)	Recruiting	Jonesboro	Arkansas	72401	United States