The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
Study identification
- NCT ID
- NCT04559945
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,276 participants
Conditions and interventions
Conditions
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 13, 2020 (Actual)
- Primary completion
- Jul 18, 2022 (Actual)
- Completion
- Sep 15, 2023 (Actual)
- Last update posted
- May 20, 2026
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 May 20, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04559945 live on ClinicalTrials.gov.