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Aveir DR i2i Study

Primary Purpose

Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia

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

About this trial

This is an interventional treatment trial for Cardiac Pacemaker, Artificial focused on measuring Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
  2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
  3. Subject has a life expectancy of at least one year
  4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
  5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
  2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
  3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
  4. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
  5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
  6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
  7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
  9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
  10. Subject is unable to read or write

Sites / Locations

  • Cardiology Associates of Mobile, Inc.
  • HonorHealth
  • Arrhythmia Research Group
  • Arkansas Heart Hospital
  • Kaiser Permanente Los Angeles Medical Center
  • USC University Hospital
  • Cedars-Sinai Medical Center
  • Premier Cardiology, Inc
  • Providence Medical Foundation
  • Huntington Memorial Hospital
  • University of California at San Diego (UCSD) Medical Center
  • Pacific Heart Institute
  • South Denver Cardiology Associates PC
  • Washington Hospital Center
  • Baptist Medical Center
  • Naples Heart Rhythm Specialists, PA
  • AdventHealth Orlando
  • Sarasota Memorial Hospital
  • Piedmont Heart Institute
  • Emory University Hospital
  • Rush University Medical Center
  • Prairie Education & Research Cooperative
  • Iowa Heart Center
  • Kansas City Cardiac Arrhythmia Research Foundation
  • Baptist Health Lexington
  • Charlton Memorial Hospital
  • Sparrow Clinical Research Institute
  • Providence Hospital
  • Mayo Clinic
  • Bryan Heart
  • Catholic Medical Center
  • Jersey Shore University Medical Center
  • North Shore University Hospital
  • New York University Hospital
  • New York Presbyterian Hospital/Cornell University
  • Mount Sinai Hospital
  • New York-Presbyterian/Columbia University Medical Center
  • Cardiac Arrhythmia & Pacemaker Center
  • Wake Forest University Medical Center Clinical Sciences
  • The Cleveland Clinic Foundation
  • Ohio Health Research Institute
  • Hightower Clinical
  • Oklahoma Heart Hospital South
  • Providence St. Vincent Medical Center
  • Lancaster General Hospital
  • University of Pittsburgh Medical Center
  • Donald Guthrie Foundation for Education & Research
  • Pinnacle Health System
  • Sanford USD Medical Center
  • Vanderbilt Heart & Vascular Institute
  • Texas Cardiac Arrhythmia
  • The Methodist Hospital
  • South Texas Cardiovascular Consultants
  • Memorial Hermann Hospital
  • University of Utah Hospital
  • Franciscan Heart & Vascular Associates
  • Aurora Medical Group
  • Aspirus Wausau Hospital
  • Kepler Universitätsklinikum GmbH
  • UZ Gasthuisberg
  • Foothills Medical Centre
  • HSC, Eastern Health
  • QE II Health Sciences
  • Southlake Regional Health Centre
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Nemocnice Na Homolce
  • Hopital d'adulte de la Timone
  • CHRU Albert Michallon
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Centro Cardiologico Monzino
  • Azienda Ospedaliero Universitaria Pisana
  • Kokura Memorial Hospital
  • Kurashiki Central Hospital
  • National Cerebral & Cardiovascular Center Hospital
  • Tokyo Women's Medical University
  • Amsterdam Academic Medical Centre (AMC)
  • Hospital Universitario de Badajoz
  • Hospital Clínic de Barcelona
  • National Taiwan University Hospital
  • John Radcliffe Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Non randomized arm

Outcomes

Primary Outcome Measures

Number of Subjects Free from Aveir DR System-Related Complications
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects
Number of Subjects Free from Aveir DR System-Related Complications
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects
Percentage of Subjects with a Ventricular Beat Followed by an Atrial Beat
AV synchrony success rate at rest while seated in de novo subjects defined as the percentage of subjects with a ventricular paced or sensed beat followed by an atrial paced or sensed beat.

Secondary Outcome Measures

Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications
Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications
Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects
Appropriate Rate Response of the Aveir Atrial Leadless Pacemaker During Exercise Testing
Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects during graded exercise testing

Full Information

First Posted
February 9, 2022
Last Updated
July 17, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05252702
Brief Title
Aveir DR i2i Study
Official Title
Aveir Dual-Chamber Leadless i2i IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

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, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
Detailed Description
The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker. Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
Keywords
Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, international, single-arm, pivotal investigational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Non randomized arm
Intervention Type
Device
Intervention Name(s)
Aveir DR Leadless Pacemaker System
Intervention Description
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Primary Outcome Measure Information:
Title
Number of Subjects Free from Aveir DR System-Related Complications
Description
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects
Time Frame
3 months
Title
Number of Subjects Free from Aveir DR System-Related Complications
Description
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects
Time Frame
12 months
Title
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements
Description
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects
Time Frame
3 months
Title
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements
Description
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects
Time Frame
12 months
Title
Percentage of Subjects with a Ventricular Beat Followed by an Atrial Beat
Description
AV synchrony success rate at rest while seated in de novo subjects defined as the percentage of subjects with a ventricular paced or sensed beat followed by an atrial paced or sensed beat.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications
Description
Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects
Time Frame
3 months
Title
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications
Description
Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects
Time Frame
12 months
Title
Appropriate Rate Response of the Aveir Atrial Leadless Pacemaker During Exercise Testing
Description
Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects during graded exercise testing
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines Subject is ≥ 18 years of age or age of legal consent, whichever age is greater Subject has a life expectancy of at least one year Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC Exclusion Criteria: Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments) Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker) Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators) Subject is unable to read or write
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Harbert
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology Associates of Mobile, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arrhythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Premier Cardiology, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Providence Medical Foundation
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California at San Diego (UCSD) Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92118-8411
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Naples Heart Rhythm Specialists, PA
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Kansas City Cardiac Arrhythmia Research Foundation
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Charlton Memorial Hospital
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
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
New York-Presbyterian/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cardiac Arrhythmia & Pacemaker Center
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Wake Forest University Medical Center Clinical Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Oklahoma Heart Hospital South
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Donald Guthrie Foundation for Education & Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Pinnacle Health System
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Vanderbilt Heart & Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Memorial Hermann Hospital
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Franciscan Heart & Vascular Associates
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Kepler Universitätsklinikum GmbH
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4021
Country
Austria
Facility Name
UZ Gasthuisberg
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
HSC, Eastern Health
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
QE II Health Sciences
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y2P9
Country
Canada
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Nemocnice Na Homolce
City
Prague
Country
Czechia
Facility Name
Hopital d'adulte de la Timone
City
Marseille
State/Province
Alpes
ZIP/Postal Code
13005
Country
France
Facility Name
CHRU Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hk Sar
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
HK SAR
Country
Hong Kong
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki-shi
State/Province
Okayama
Country
Japan
Facility Name
National Cerebral & Cardiovascular Center Hospital
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Tokyo
Country
Japan
Facility Name
Amsterdam Academic Medical Centre (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
State/Province
Extmdra
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Soeast
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.
IPD Sharing Time Frame
IPD will be available following publication of primary results for 25 years following study completion date.
IPD Sharing Access Criteria
Proposals for requesting individual data may be submitted to the Sponsor at AveirDR_IDE@abbott.com.

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Aveir DR i2i Study

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