Recruiting NCT07287423

LEAP 2 Chronic EFS

No phase Interventional Cardiac Pacemaker Cardiac Rhythm Disorder Bradycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AVEIR CSP Leadless Pacemaker System.
Who it may be relevant to: Registry conditions: Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Czechia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

LEadless Advanced Pacing 2 Chronic Early Feasibility Study

Overview

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.

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, 2 months, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Interventions

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.

Primary outcome measures

Percentage of Participants Free From AVEIR CSP related Complications at 1-month [Time frame: 1 month]
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month [Time frame: 1 month]

Secondary outcome measures (2)

Percentage of Participants Free From AVEIR CSP related Complications at 3-months [Time frame: 3 months]
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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
Subject is unable to read or write

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Czechia · 1 center

Nemocnice Na Homolce — Prague

Identifiers

NCT: NCT07287423 · ABT-CIP-10614

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗