Safety and Performance Study of the INGEVITY Lead

March 2, 2020 updated by: Boston Scientific Corporation

INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads

Study Type

Interventional

Enrollment (Actual)

1060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4001
        • St. Andrew's War Memorial Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Univ.-Kliniken Graz
      • Linz, Austria, 4021
        • AKH Linz
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Kortrijk, Belgium, 8500
        • AZ Groeninge Campus
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W IT7
        • Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
  • Denmark
      • Aarhus, Denmark, 8200
        • Skejby Sygehus
      • Roskilde, Denmark, 4000
        • Roskilde University Hospital
  • France
      • Marseille Cedex 05, France, 13005
        • CHU La Timone Hospital
      • Nantes Cedex 2, France, 44277
        • NCN Nouvelles Cliniques Nantaises
  • Germany
      • Chemnitz, Germany, 09116
        • Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
      • Cologne, Germany, 50931
        • Uniklinik Köln
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universitaet Magdeburg
  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Prince of Wales Hospital
  • Italy
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
      • Kuala Lumpur, Malaysia, 50603
        • University of Malaya Medical Centre
  • Portugal
      • Porto, Portugal, 4099 - 001
        • Centro Hospitalar do Porto - Hospital de Santo António
      • Santarem, Portugal, 2005-177
        • Hospital de Santarem
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico Y Provincial
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
      • Valladolid, Spain, 47012
        • Clinico de Valladolid
  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Chiang Mai Heart Center Medical School Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT9 7
        • Belfast City Hospital
      • Wrexham, United Kingdom, LL13 7TD
        • Wrexham Maelor Hospital
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Basildon and Thurrock University Hospitals NHS
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Glendale, Arizona, United States, 85306
        • Cardiovascular Consultants, Ltd
      • Tucson, Arizona, United States, 85712
        • Pima Heart Physicians, PC
    • California
      • La Mesa, California, United States, 91942
        • Sharp Grossmont Hospital
      • Orange, California, United States, 92868
        • Orange County Heart Institute
      • Rancho Mirage, California, United States, 92270-3221
        • Eisenhower Medical Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Trumbull, Connecticut, United States, 06611
        • Cardiology Associates of Fairfield County
    • Florida
      • Largo, Florida, United States, 33770
        • West Florida Cardiology Network, LLC
      • Tampa, Florida, United States, 33613
        • University Community Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • WellStar Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent's Hospital
      • LaPorte, Indiana, United States, 46350
        • Indiana University Health La Porte Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Southern Kentucky Heart Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Saginaw, Michigan, United States, 48601
        • Michigan CardioVascular Institute
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast St. Joseph's Hospital
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Cardiovascular Associates of the Delaware Valley
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Staten Island, New York, United States, 10309
        • Staten Island University Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Cincinnati, Ohio, United States, 45219
        • Lindner Center for Research and Education at Christ Hosp
      • Cincinnati, Ohio, United States, 45219
        • University Hospital, Inc.
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology Consultants
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Coastal Cardiology
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Heart Hospital of Austin
      • Austin, Texas, United States, 78745
        • South Austin Hospital
      • Dallas, Texas, United States, 75231
        • North Texas Heart Center
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Fort Worth
      • Tyler, Texas, United States, 75701
        • Trinity Mother Frances Health System
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital and Clinics
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Bon Secours Heart & Vascular Institute
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth St. Joseph Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Monongalia General Hospital
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital Inc.
    • Wisconsin
      • Glendale, Wisconsin, United States, 53212
        • Wheaton Franciscan Healthcare
      • Madison, Wisconsin, United States, 53715
        • St. Mary's Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is willing and capable of providing informed consent
  • Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines
  • Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  • Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  • Subject has or has had any pacing or ICD system implants
  • Subject has a sensitivity to dexamethasone acetate (DXA)
  • Subject has a mechanical tricuspid heart valve
  • Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries
  • Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable)
  • Subject is currently on the active heart transplant list
  • Subject has documented life expectancy of less than 12 months
  • Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant
  • Subjects currently requiring dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INGEVITY lead
INGEVITY lead implant
Device: INGEVITY lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
Time Frame: Lead implant through 3 month follow up
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Lead implant through 3 month follow up
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
Time Frame: 3 months through 12 months post implant
Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
3 months through 12 months post implant
Safety 3 - Hazard Rate of Lead-Related Complications
Time Frame: Implant through 12 months (including available data beyond 12 months)
Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
Implant through 12 months (including available data beyond 12 months)
Effectiveness 1
Time Frame: Lead implant through 3 month follow up
The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V
Lead implant through 3 month follow up
Effectiveness 2(Right Atrium)
Time Frame: Lead implant through 3 month follow up
P-wave sensed amplitude at three months post-implant > 1.5 mV
Lead implant through 3 month follow up
Effectiveness 2(Right Ventricle)
Time Frame: Lead implant through 3 month follow up
R-wave sensed amplitude at three months post-implant > 5 mV
Lead implant through 3 month follow up
Effectiveness 3
Time Frame: Lead implant through 3 month follow up
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
Lead implant through 3 month follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary Safety
Time Frame: From 3 to 60 months post-implant
Lead-related complication-free rate
From 3 to 60 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Charles Love, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSC-CDM00048360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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