AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)

NCT06782152 | Not Yet Recruiting

• 1 other identifier: Version A
• Study Type: observational
• Target: 1,698
• Locations: 0 countries
• Sites: N/A

Brief Summary

The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices.

Conditions

Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines

Keywords

Bradycardia; Sick Sinus Syndrome; Pacemaker; AV Block; Vasovagal Syncope; Heart Diseases; Cardiovascular Diseases; Pathologic Proceses; Arrhytmias, Cardiac

Outcome Measures

Primary Outcomes (3)

• The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems

  Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision AveirTM LP systems

  12 momths

• Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months.

  Ventricular pacing threshold is considered acceptable if \<2.0 V at 0.4 ms and R-wave amplitude is considered acceptable if \>5.0 mV or ≥ of the implant value

  12 months

• Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months.

  atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms and atrial sensing Amplitude is considered adequate if P wave ≥1.0 mV.

  12 months

Secondary Outcomes (13)

• Freedom from device- or procedure-related major complications at 24 months

  24 months

• All adverse events, regardless device- or procedure-relatedness.

  48 months

• Implant success rate and reasons for unsuccessful implant.

  24 months

• Number of device repositioning at time of implantation.

  24 months

• Implant duration, fluoroscopy duration, and time from implant to hospital discharge.

  24 months

Eligibility Criteria

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

Study Population

Subject clinically indicated to receive a Leadless Pacemaker in adherence with ESC cardiac pacing guidelines.

You may qualify if:

• Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
• Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
• Subject agrees to return to clinic for the study follow-up visits.
• Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by IRB/EC.

You may not qualify if:

• Subject is currently participating in another study that may confound the results of this research.
• Subject has a life expectancy less than 12 months.
• Subject is pregnant or nursing or planning pregnancy during the study.
• Subject has 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 study or to comply with the site standard follow-up visits, for example a mechanical tricuspid
• \- Page 3 of 4 \[DRAFT\] - valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.
• Subject is allergic/hypersensitive to \<1 mg dexamethasone sodium phosphate.
• Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
• Subject has known pacemaker syndrome, if that condition, in the investigator's opinion, represents a contraindication to the implant of the planned pacemaker.
• Subject has pacing induced cardiomyopathy.

Sponsors & Collaborators

• King Fahad Armed Forces Hospital: lead

MeSH Terms

Conditions

Bradycardia; Sick Sinus Syndrome; Atrioventricular Block; Syncope, Vasovagal; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director - Head of Cardiology

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 17, 2025

Record last verified: 2025-01