Safety and Performance Study of the INGEVITY Lead

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688843
• Other study ID #: BSC-CDM00048360
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: February 2019

Study information

• Verified date: March 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: February 2019
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Device:
• INGEVITY lead

Locations

Country	Name	City	State
Australia	St. Andrew's War Memorial Hospital	Brisbane	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Austria	Medizinische Univ.-Kliniken Graz	Graz
Austria	AKH Linz	Linz
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge Campus	Kortrijk
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Denmark	Skejby Sygehus	Aarhus
Denmark	Roskilde University Hospital	Roskilde
France	CHU La Timone Hospital	Marseille Cedex 05
France	NCN Nouvelles Cliniques Nantaises	Nantes Cedex 2
Germany	Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner	Chemnitz
Germany	Uniklinik Köln	Cologne
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg
Hong Kong	Prince of Wales Hospital	Shatin
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona
Malaysia	Institut Jantung Negara	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Portugal	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto
Portugal	Hospital de Santarem	Santarem
Spain	Hospital Clinico Y Provincial	Barcelona
Spain	Hospital Universitario Nuestra Senora de Candelaria	Santa Cruz de Tenerife
Spain	Hospital Doctor Peset	Valencia
Spain	Clinico de Valladolid	Valladolid
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Karolinska University Hospital	Stockholm
Thailand	Chiang Mai Heart Center Medical School Hospital	Chiang Mai
United Kingdom	Basildon and Thurrock University Hospitals NHS	Basildon	Essex
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Wrexham Maelor Hospital	Wrexham
United States	Heart Hospital of Austin	Austin	Texas
United States	South Austin Hospital	Austin	Texas
United States	PeaceHealth St. Joseph Medical Center	Bellingham	Washington
United States	Southern Kentucky Heart Institute	Bowling Green	Kentucky
United States	New York Methodist Hospital	Brooklyn	New York
United States	Aultman Hospital	Canton	Ohio
United States	Coastal Cardiology	Charleston	South Carolina
United States	Lindner Center for Research and Education at Christ Hosp	Cincinnati	Ohio
United States	University Hospital, Inc.	Cincinnati	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	North Texas Heart Center	Dallas	Texas
United States	Danbury Hospital	Danbury	Connecticut
United States	Henry Ford Hospital	Detroit	Michigan
United States	Plaza Medical Center of Fort Worth	Fort Worth	Texas
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Cardiovascular Consultants, LTD	Glendale	Arizona
United States	Wheaton Franciscan Healthcare	Glendale	Wisconsin
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Sharp Grossmont Hospital	La Mesa	California
United States	Indiana University Health La Porte Hospital	LaPorte	Indiana
United States	West Florida Cardiology Network, LLC	Largo	Florida
United States	St. Mary's Madison	Madison	Wisconsin
United States	Wellstar Research Institute	Marietta	Georgia
United States	Monongalia General Hospital	Morgantown	West Virginia
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Orange County Heart Institute	Orange	California
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Bon Secours Heart & Vascular Institute	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	Michigan CardioVascular Institute	Saginaw	Michigan
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Staten Island University Hospital	Staten Island	New York
United States	University Community Hospital	Tampa	Florida
United States	Northwest Ohio Cardiology Consultants	Toledo	Ohio
United States	Cardiology Associates of Fairfield County	Trumbull	Connecticut
United States	Pima Heart Physicians, PC	Tucson	Arizona
United States	Trinity Mother Frances Health System	Tyler	Texas
United States	Wheeling Hospital Inc.	Wheeling	West Virginia
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Hong Kong,  Italy,  Malaysia,  Portugal,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ancillary Safety	Lead-related complication-free rate	From 3 to 60 months post-implant
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	Effectiveness 2(Right Atrium)	P-wave sensed amplitude at three months post-implant > 1.5 mV	Lead implant through 3 month follow up
Primary	Effectiveness 2(Right Ventricle)	R-wave sensed amplitude at three months post-implant > 5 mV	Lead implant through 3 month follow up
Primary	Effectiveness 3	Clinically acceptable pacing impedance between 300 O and 1300 O	Lead implant through 3 month follow up