LEAP 2 Chronic EFS

NCT07287423 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10614
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Pacemaker; Cardiac Rhythm Disorder; Bradycardia

Keywords

Bradycardia; Sick Sinus Syndrome; Pacemaker; Leadless; Conduction System Pacing; LBBAP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of Participants Free From AVEIR CSP related Complications at 3-months

  3 months

• Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months

  3 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Device: AVEIR CSP Leadless Pacemaker System

Interventions

AVEIR CSP Leadless Pacemaker System DEVICE

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have at least one standard pacemaker indication
• Subject must be at least 18 years of age
• Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
• 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

You may not qualify if:

• Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
• Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
• Subject has previous myocardial infarction
• Subject is expected to be pacemaker dependent
• 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)
• Subject has an active implantable electronic device that cannot be turned off during the study procedure
• Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
• 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
• Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Subject has known chronic renal insufficiency including patients on dialysis
• Subject has an active systemic infection
• Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
• Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Nemocnice Na Homolce

Prague, Czechia

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Study Officials

• Vivek Y Reddy, MD

  The Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, non-randomized, unblinded, chronic feasibility study

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 17, 2025
• Study Start: December 13, 2025
• Primary Completion: March 16, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available following publication of primary results for 25 years following study completion date.

Locations

CZ (1)