The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Public ClinicalTrials.gov record NCT02030418. 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 I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker. Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
Study identification
- NCT ID
- NCT02030418
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 952 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
- Feb 2014 (Actual)
- Primary completion
- Jun 2015 (Actual)
- Completion
- Jul 15, 2022 (Actual)
- Last update posted
- Jul 9, 2025
2014 – 2022
United States locations
- U.S. sites
- 50
- U.S. states
- 25
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Heart Center Research, LLC. | Huntsville | Alabama | 35801 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| USC University Hospital | Los Angeles | California | 90033 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| Premier Cardiology, Inc | Newport Beach | California | 92663 | — |
| Huntington Memorial Hospital | Pasadena | California | 91105 | — |
| Sequoia Hospital | Redwood City | California | 94303 | — |
| Mercy Medical Group - Cardiology | Sacramento | California | 95819 | — |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | — |
| Naples Community Hospital | Naples | Florida | 34102 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30306 | — |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| St. Elizabeth Medical Center | Edgewood | Kentucky | 41017 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | — |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Sparrow Research | Lansing | Michigan | 48910 | — |
| Munson Medical Center | Traverse | Michigan | 49684 | — |
| Michigan Heart | Ypsilanti | Michigan | 48197 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07712 | — |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Cardiac Arrhythmia and Pacemaker Center | Roslyn | New York | 11576 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cone Health Medical Group HeartCare | Greensboro | North Carolina | 27401 | — |
| University Hospitals of Cleveland | 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 | — |
| Clinical Tex Research, LLC | Amarillo | Texas | 79106 | — |
| Memorial Hermann Hospital | Houston | Texas | 77380 | — |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | — |
| Intermountain Heart Rhythm Specialists | Murray | Utah | 84107 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22031 | — |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | — |
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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02030418, 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 Jul 9, 2025 · 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 NCT02030418 live on ClinicalTrials.gov.