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The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Leadless Pacemaker
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

    • Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
    • Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
    • Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
  2. Subject ≥18 years of age; and
  3. Subject has life expectancy of at least one year; and
  4. Subject is not enrolled in another clinical investigation; and
  5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
  6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and
  7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

  1. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
  2. Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or
  3. Subject has a mechanical tricuspid valve prosthesis; or
  4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
  5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
  6. Subject has an implanted vena cava filter; or
  7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
  8. Subject has an implanted leadless cardiac pacemaker; or
  9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment

Sites / Locations

  • University Hospital - Univ. of Alabama at Birmingham
  • Heart Center Research, LLC.
  • Scripps Health
  • USC University Hospital
  • El Camino Hospital
  • Premier Cardiology, Inc
  • Huntington Memorial Hospital
  • Sequoia Hospital
  • Mercy Medical Group - Cardiology
  • South Denver Cardiology Associates PC
  • Naples Community Hospital
  • AdventHealth Orlando
  • Orlando Health
  • Piedmont Athens Regional Medical Center
  • Redmond Regional Medical Center
  • University of Chicago
  • Advocate Christ Medical Center
  • Parkview Research Center
  • Kansas University Medical Center
  • St. Elizabeth Medical Center
  • Baptist Health Lexington
  • Ochsner Medical Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Lahey Clinic Medical Center
  • St. John Hospital and Medical Center
  • Sparrow Research
  • Munson Medical Center
  • Michigan Heart
  • Fairview Southdale Hospital
  • Mayo Clinic
  • Mercy Hospital St. Louis
  • Jersey Shore University Medical Center
  • New York Presbyterian Hospital/Cornell University
  • Mount Sinai Hospital
  • Cardiac Arrhythmia and Pacemaker Center
  • Duke University Medical Center
  • Cone Health Medical Group HeartCare
  • University Hospitals of Cleveland
  • The Cleveland Clinic Foundation
  • Integris Baptist Medical Center
  • University of Pittsburgh Medical Center
  • WellSpan Health
  • Methodist University Hospital
  • Clinical Tex Research, LLC
  • Memorial Hermann Hospital
  • South Texas Cardiovascular Consultants
  • Intermountain Heart Rhythm Specialists
  • Inova Fairfax Hospital
  • Aurora Medical Group
  • The Prince Charles Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Foothills Medical Centre
  • Vancouver General Hospital (U of BC)
  • Kinsgston General Hospital
  • Southlake Regional Health Centre
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Institut de Cardiologie de Quebec (Hospital Laval)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leadless Pacemaker

Arm Description

VVIR pacing

Outcomes

Primary Outcome Measures

Complication-Free Rate
Pacing thresholds and R-wave amplitudes within the therapeutic range

Secondary Outcome Measures

appropriate and proportional rate response during graded exercise testing

Full Information

First Posted
January 6, 2014
Last Updated
December 16, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02030418
Brief Title
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Official Title
The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leadless Pacemaker
Arm Type
Experimental
Arm Description
VVIR pacing
Intervention Type
Device
Intervention Name(s)
Leadless Pacemaker
Intervention Description
Patients will undergo an attempted leadless pacemaker implant
Primary Outcome Measure Information:
Title
Complication-Free Rate
Time Frame
6 months
Title
Pacing thresholds and R-wave amplitudes within the therapeutic range
Time Frame
6 months
Secondary Outcome Measure Information:
Title
appropriate and proportional rate response during graded exercise testing
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including: Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and Subject ≥18 years of age; and Subject has life expectancy of at least one year; and Subject is not enrolled in another clinical investigation; and Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and Subject is not pregnant and does not plan to get pregnant during the course of the study. Exclusion Criteria: Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or Subject has a mechanical tricuspid valve prosthesis; or Subject has a pre-existing endocardial pacing or defibrillation leads; or Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or Subject has an implanted vena cava filter; or Subject has evidence of thrombosis in one of the veins used for access during the procedure; or Subject has an implanted leadless cardiac pacemaker; or Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivik Reddy, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital - Univ. of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Heart Center Research, LLC.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Premier Cardiology, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Mercy Medical Group - Cardiology
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Naples Community Hospital
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Piedmont Athens Regional Medical Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Redmond Regional Medical Center
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
St. Elizabeth Medical Center
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Sparrow Research
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Munson Medical Center
City
Traverse
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
New York Presbyterian Hospital/Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cardiac Arrhythmia and Pacemaker Center
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cone Health Medical Group HeartCare
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
WellSpan Health
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Clinical Tex Research, LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Intermountain Heart Rhythm Specialists
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Vancouver General Hospital (U of BC)
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Kinsgston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Institut de Cardiologie de Quebec (Hospital Laval)
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27932427
Citation
Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.
Results Reference
derived
PubMed Identifier
26321198
Citation
Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, Friedman PA, Estes NA 3rd, Ip J, Niazi I, Plunkitt K, Banker R, Porterfield J, Ip JE, Dukkipati SR; LEADLESS II Study Investigators. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. 2015 Sep 17;373(12):1125-35. doi: 10.1056/NEJMoa1507192. Epub 2015 Aug 30.
Results Reference
derived

Learn more about this trial

The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

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