LEAP 2 Chronic EFS

LEadless Advanced Pacing 2 Chronic Early Feasibility Study

Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.

Study Overview

• Status: Active, not recruiting
• Conditions: Bradycardia; Cardiac Rhythm Disorder; Cardiac Pacemaker
• Intervention / Treatment: Device: AVEIR CSP Leadless Pacemaker System

Detailed Description

The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications.

Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Nemocnice Na Homolce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject must have at least one standard pacemaker indication
2. Subject must be at least 18 years of age
3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC

Exclusion Criteria:

1. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
2. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
3. Subject has previous myocardial infarction
4. Subject is expected to be pacemaker dependent
5. Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
6. Subject has an active implantable electronic device that cannot be turned off during the study procedure
7. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
8. Subject has known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure
9. Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
10. Subject has known chronic renal insufficiency including patients on dialysis
11. Subject has an active systemic infection
12. Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
13. Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
15. 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 the follow-up requirements of the clinical investigation
16. Subject is unable to read or write

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Device: AVEIR CSP Leadless Pacemaker System; Patients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Free From AVEIR CSP related Complications at 1-month	AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.	1 month
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month	Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Free From AVEIR CSP related Complications at 3-months	AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.	3 months
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months	Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 3 months.	3 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Vivek Y Reddy, MD, The Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2025
• Primary Completion (Actual): March 16, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pacemaker; Bradycardia; Leadless; Sick Sinus Syndrome; LBBAP; Conduction System Pacing
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Block; Arrhythmia, Sinus; Pathological Conditions, Signs and Symptoms; Sick Sinus Syndrome; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: ABT-CIP-10614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Study Principal Investigator
• IPD Sharing Time Frame: IPD will be available following publication of primary results for 25 years following study completion date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes