Safety and Performance Study of the INGEVITY Lead

NCT01688843 | Completed Results FDA Device

• 1 other identifier: BSC-CDM00048360
• Study Type: interventional
• Target: 1,060
• Locations: 15 countries
• Sites: 75

Brief Summary

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

Conditions

Bradycardia; Sinus Node Dysfunction

Keywords

bradycardia; sinus node dysfunction

Outcome Measures

Primary Outcomes (7)

• Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)

  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)

  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

  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

  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)

  P-wave sensed amplitude at three months post-implant \> 1.5 mV

  Lead implant through 3 month follow up

• Effectiveness 2(Right Ventricle)

  R-wave sensed amplitude at three months post-implant \> 5 mV

  Lead implant through 3 month follow up

• Effectiveness 3

  Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

  Lead implant through 3 month follow up

Other Outcomes (1)

• Ancillary Safety

  From 3 to 60 months post-implant

Study Arms (1)

INGEVITY lead

EXPERIMENTAL

INGEVITY lead implant

Device: INGEVITY lead

Interventions

INGEVITY lead DEVICE

INGEVITY lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (78)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Cardiovascular Consultants, LTD

Glendale, Arizona, 85306, United States

Location

Pima Heart Physicians, PC

Tucson, Arizona, 85712, United States

Location

Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

Orange County Heart Institute

Orange, California, 92868, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270-3221, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Cardiology Associates of Fairfield County

Trumbull, Connecticut, 06611, United States

Location

West Florida Cardiology Network, LLC

Largo, Florida, 33770, United States

Location

University Community Hospital

Tampa, Florida, 33613, United States

Location

Wellstar Research Institute

Marietta, Georgia, 30060, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States

Location

Indiana University Health La Porte Hospital

La Porte, Indiana, 46350, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Southern Kentucky Heart Institute

Bowling Green, Kentucky, 42101, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan CardioVascular Institute

Saginaw, Michigan, 48601, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, 08080, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Staten Island University Hospital

Staten Island, New York, 10309, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Lindner Center for Research and Education at Christ Hosp

Cincinnati, Ohio, 45219, United States

Location

University Hospital, Inc.

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Coastal Cardiology

Charleston, South Carolina, 29407, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

South Austin Hospital

Austin, Texas, 78745, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

North Texas Heart Center

Dallas, Texas, 75231, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Bon Secours Heart & Vascular Institute

Richmond, Virginia, 23230, United States

Location

PeaceHealth St. Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Wheeling Hospital Inc.

Wheeling, West Virginia, 26003, United States

Location

Wheaton Franciscan Healthcare

Glendale, Wisconsin, 53212, United States

Location

St. Mary's Madison

Madison, Wisconsin, 53715, United States

Location

St. Andrew's War Memorial Hospital

Brisbane, Queensland, 4001, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Medizinische Univ.-Kliniken Graz

Graz, 8036, Austria

Location

AKH Linz

Linz, 4021, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

AZ Groeninge Campus

Kortrijk, 8500, Belgium

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W IT7, Canada

Location

Skejby Sygehus

Aarhus, 8200, Denmark

Location

Roskilde University Hospital

Roskilde, 4000, Denmark

Location

CHU La Timone Hospital

Marseille, 13005, France

Location

NCN Nouvelles Cliniques Nantaises

Nantes, 44277, France

Location

Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner

Chemnitz, 09116, Germany

Location

Uniklinik Köln

Cologne, 50931, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, 39120, Germany

Location

Prince of Wales Hospital

Shatin, 999077, Hong Kong

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Centro Hospitalar do Porto - Hospital de Santo Antonio

Porto, 4099 - 001, Portugal

Location

Hospital de Santarem

Santarém, 2005-177, Portugal

Location

Hospital Clinico Y Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Doctor Peset

Valencia, 46017, Spain

Location

Clinico de Valladolid

Valladolid, 47012, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Chiang Mai Heart Center Medical School Hospital

Chiang Mai, 50200, Thailand

Location

Basildon and Thurrock University Hospitals NHS

Basildon, Essex, SS16 5NL, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, LL13 7TD, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Results Point of Contact

• Title: Gena Kantor, MPH
• Organization: Boston Scientific

gena.kantor@bsci.com

1-800-227-3422

Study Officials

• Charles Love, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2019
• Last Updated: March 10, 2020
• Results First Posted: November 17, 2017

Record last verified: 2020-03

Locations

DK (2); CA (3); DE (4); GB (3); AU (2); BE (2); IT (1); ES (4); FR (2); PT (2); US (44); MY (2); HK (1); SE (2); TH (1)