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Lead EvaluAtion for Defibrillation and Reliability (LEADR)

Primary Purpose

Tachyarrhythmia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Defibrillation
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachyarrhythmia

Eligibility Criteria

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

Inclusion Criteria:

  • Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:

    • de novo Medtronic CRT-D system implant
    • de novo Medtronic ICD system implant (single or dual chamber)
  • Subject has, per local law and requirements, the minimum age for autonomously signing an ICF
  • Subject is willing to undergo implant defibrillation testing if requested.
  • Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.

Exclusion Criteria:

  • Subject is unwilling or unable to personally provide Informed Consent.
  • Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
  • Subject is contraindicated for ≤1 mg dexamethasone acetate.
  • Subject has a life expectancy of less than 12 months

  • For subject undergoing defibrillation testing the following medical conditions exclude them:

    • Pre-existing or suspected pneumothorax during implant
    • Current intracardiac left atrial or left ventricular (LV) thrombus
    • Severe aortic stenosis
    • Severe proximal three-vessel or left main coronary artery disease without revascularization
    • Unstable angina
    • Ejection Fraction less than 25%
    • Recent stroke or transient ischemic attack (within the last 6 months)
    • Known inadequate external defibrillation
    • Any other known medical condition not listed that precludes their participation in the opinion of the investigator
  • Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
  • Subject with any exclusion criteria as required by local law (e.g., age or other).
  • Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
  • Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
  • Subject with any evidence of active infection or undergoing treatment for an infection
  • Recent (or planned) cardiac surgery or stenting less than 1 month before implant
  • End stage renal disease
  • Subjects with NYHA IV classification
  • Subjects with a transplanted heart
  • Subjects with previously extracted leads
  • Subjects with Left Ventricular Assist Device

Sites / Locations

  • Heart Center Research
  • Hartford Hospital
  • University of South Florida
  • Minneapolis Heart Institute Foundation
  • Saint Luke's Mid America Heart Institute
  • Washington University School of Medicine
  • Lourdes Cardiology Services
  • Presbyterian Heart Group
  • South Shore University Hospital
  • TriHealth Hatton Research Institute
  • Cleveland Clinic
  • Lehigh Valley Hospital - Cedar Crest
  • Hospital of the University of Pennsylvania
  • The Children's Hospital of Philadelphia
  • Vanderbilt University medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • Texas Health Fort Worth Hospital
  • University of Virginia Medical Center
  • Virginia Commonwealth University Health System
  • The Prince Charles Hospital
  • Ashford Hospital
  • Royal Adelaide
  • Canberra Hospital
  • Universitätsklinikum Krems
  • University of Calgary
  • Southlake Regional Health Centre
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Shanxi Cardiovascular Hospital
  • West China Hospital of Sichuan University
  • Queen Mary Hospital
  • Rigshospitalet
  • Centre Hospitalier Universitaire de Grenoble - Site Nord
  • CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
  • Klinikum Bielefeld Kardiologie
  • Princess Margaret Hospital
  • Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
  • Kokura Memorial Hospital
  • National Cerebral and Cardiovascular Center
  • Tokyo Women's Medical University Hospital
  • Institut Jantung Negara - National Heart Institute
  • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
  • Klinicki Centar Srbije Pejsmejker centar
  • Ng Teng Fong General Hospital
  • Hospital Universitari Bellvitge
  • Hospital Universitario y Politécnico La Fe
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention/Treatment

Arm Description

Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing

Outcomes

Primary Outcome Measures

Estimate the rate of major Lead complication-free rate at 6 months
Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.
Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Defibrillation testing will be completed in a subset of subjects at implant.

Secondary Outcome Measures

Estimate the fracture-free rate of the Next Generation ICD lead
Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.

Full Information

First Posted
April 21, 2021
Last Updated
October 16, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT04863664
Brief Title
Lead EvaluAtion for Defibrillation and Reliability (LEADR)
Official Title
Lead EvaluAtion for Defibrillation and Reliability (LEADR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

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
The study is designed to assess the safety and efficacy of the Next Generation ICD lead.
Detailed Description
The study will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects will be followed for at least 18 months following Next Generation ICD Lead implantation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention/Treatment
Arm Type
Experimental
Arm Description
Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing
Intervention Type
Device
Intervention Name(s)
Defibrillation
Intervention Description
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Primary Outcome Measure Information:
Title
Estimate the rate of major Lead complication-free rate at 6 months
Description
Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.
Time Frame
Implant to 6 Months
Title
Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Description
Defibrillation testing will be completed in a subset of subjects at implant.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Estimate the fracture-free rate of the Next Generation ICD lead
Description
Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following: de novo Medtronic CRT-D system implant de novo Medtronic ICD system implant (single or dual chamber) Subject has, per local law and requirements, the minimum age for autonomously signing an ICF Subject is willing to undergo implant defibrillation testing if requested. Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up. Exclusion Criteria: Subject is unwilling or unable to personally provide Informed Consent. Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve). Subject is contraindicated for ≤1 mg dexamethasone acetate. Subject has a life expectancy of less than 12 months For subject undergoing defibrillation testing the following medical conditions exclude them: Pre-existing or suspected pneumothorax during implant Current intracardiac left atrial or left ventricular (LV) thrombus Severe aortic stenosis Severe proximal three-vessel or left main coronary artery disease without revascularization Unstable angina Ejection Fraction less than 25% Recent stroke or transient ischemic attack (within the last 6 months) Known inadequate external defibrillation Any other known medical condition not listed that precludes their participation in the opinion of the investigator Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. Subject with any exclusion criteria as required by local law (e.g., age or other). Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads Subject with any evidence of active infection or undergoing treatment for an infection Recent (or planned) cardiac surgery or stenting less than 1 month before implant End stage renal disease Subjects with NYHA IV classification Subjects with a transplanted heart Subjects with previously extracted leads Subjects with Left Ventricular Assist Device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Crossley, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Saint Luke's Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Presbyterian Heart Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
South Shore University Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
TriHealth Hatton Research Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Health Fort Worth Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Ashford Hospital
City
Ashford
State/Province
South Australia
ZIP/Postal Code
8032
Country
Australia
Facility Name
Royal Adelaide
City
Norwood
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Canberra Hospital
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Universitätsklinikum Krems
City
Krems
State/Province
Mitterweg
ZIP/Postal Code
3500
Country
Austria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y8C3
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Centre Hospitalier Universitaire de Grenoble - Site Nord
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Klinikum Bielefeld Kardiologie
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Princess Margaret Hospital
City
Lai Chi Kok
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Institut Jantung Negara - National Heart Institute
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Facility Name
Klinicki Centar Srbije Pejsmejker centar
City
Belgrad
Country
Serbia
Facility Name
Ng Teng Fong General Hospital
City
Singapore
Country
Singapore
Facility Name
Hospital Universitari Bellvitge
City
L'Hospitalet De Llobregat
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lead EvaluAtion for Defibrillation and Reliability (LEADR)

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