ClinicalTrials.gov record
Active, not recruiting Not applicable Interventional

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

ClinicalTrials.gov ID: NCT04559945

Public ClinicalTrials.gov record NCT04559945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

Study identification

NCT ID
NCT04559945
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
326 participants

Conditions and interventions

Interventions

  • Aveir VR Leadless Pacemaker System Device

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 12, 2020
Primary completion
Jul 17, 2022
Completion
Aug 30, 2023
Last update posted
Dec 18, 2022

2020 – 2023

United States locations

U.S. sites
38
U.S. states
23
U.S. cities
35
Facility City State ZIP Site status
University Hospital - University of Alabama at Birmingham (UAB) Birmingham Alabama 35294
The Heart Center PC Huntsville Alabama 35801
Honor Health Scottsdale Arizona 85258
University of Southern California Long Beach California 90803
Premier Cardiology Inc Newport Beach California 92663
Huntington Memorial Hospital Pasadena California 91105
South Denver Cardiology Associates PC Littleton Colorado 80120
Naples Heart Rhythm Specialists PA Naples Florida 34119
Orlando Health Orlando Florida 32806
Piedmont Athens Regional Medical Center Athens Georgia 30306
Redmond Regional Medical Center Rome Georgia 30165
Kansas University Medical Center Kansas City Kansas 66160
Kansas City Cardiac Arrhythmia Research Foundation Overland Park Kansas 66211
St. Elizabeth Medical Center - South Unit Edgewood Kentucky 41017
Baptist Health Lexington Lexington Kentucky 40503
University of Kentucky Lexington Kentucky 40536
Ochsner Medical Center New Orleans Louisiana 70121
Lahey Clinic Medical Center Burlington Massachusetts 01805
Ascension St. John Hospital Detroit Michigan 48236
Sparrow Clinical Research Institute Lansing Michigan 48912
Munson Medical Center Traverse City Michigan 49684
Mayo Clinic Rochester Minnesota 55905
Mercy Hospital St. Louis St Louis Missouri 63141
Jersey Shore University Medical Center Ocean Township New Jersey 07712
New York Presbyterian Hospital/Cornell University New York New York 10021
Mount Sinai Hospital New York New York 10029
Cardiac Arrhythmia & Pacemaker Center Roslyn New York 11576
Cone Health Medical Group HeartCare Greensboro North Carolina 27401
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
The Cleveland Clinic Foundation Cleveland Ohio 44195
Integris Baptist Medical Center Oklahoma City Oklahoma 73112
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
WellSpan Health York Pennsylvania 17405
Methodist University Hospital Memphis Tennessee 38104
South Texas Cardiovascular Consultants San Antonio Texas 78201
Memorial Hermann Hospital The Woodlands Texas 77380
University of Utah Hospital Salt Lake City Utah 84132
Inova Fairfax Hospital Falls Church Virginia 22042

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04559945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2022 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04559945 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →