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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1060

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Antonio
      • 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
        • Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INGEVITY lead
INGEVITY lead implant
Device: INGEVITY lead

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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