BradycardiaNCT01688843

Safety and Performance Study of the INGEVITY Lead

A study testing INGEVITY lead in people with Bradycardia and Sinus Node Dysfunction, run by Boston Scientific Corporation at 78 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia, Sinus Node Dysfunction
What is being tested?: INGEVITY lead
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,060 participants
Where: 78 sitesin 16 countries
Study dates: Oct 2012to Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

78 sites in 16 countries.

Country

City, postcode or hospital

78 sites in 16 countries

United States44 sites

South Austin Hospital
Austin, Texas, 78745
Heart Hospital of Austin
Austin, Texas, 78756
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, 98225
Southern Kentucky Heart Institute
Bowling Green, Kentucky, 42101
New York Methodist Hospital
Brooklyn, New York, 11215
Aultman Hospital
Canton, Ohio, 44710
Coastal Cardiology
Charleston, South Carolina, 29407
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, 45219
University Hospital, Inc.
Cincinnati, Ohio, 45219
Ohio State University Medical Center
Columbus, Ohio, 43210
North Texas Heart Center
Dallas, Texas, 75231
Danbury Hospital
Danbury, Connecticut, 06810
Henry Ford Hospital
Detroit, Michigan, 48202
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Cardiovascular Consultants, LTD
Glendale, Arizona, 85306
Wheaton Franciscan Healthcare
Glendale, Wisconsin, 53212
St. Vincent's Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Sharp Grossmont Hospital
La Mesa, California, 91942
Indiana University Health La Porte Hospital
La Porte, Indiana, 46350
West Florida Cardiology Network, LLC
Largo, Florida, 33770
St. Mary's Madison
Madison, Wisconsin, 53715
Wellstar Research Institute
Marietta, Georgia, 30060
Monongalia General Hospital
Morgantown, West Virginia, 26505
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Orange County Heart Institute
Orange, California, 92868
Eisenhower Medical Center
Rancho Mirage, California, 92270-3221
Bon Secours Heart & Vascular Institute
Richmond, Virginia, 23230
Rochester General Hospital
Rochester, New York, 14621
Michigan CardioVascular Institute
Saginaw, Michigan, 48601
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Sharp Memorial Hospital
San Diego, California, 92123
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Staten Island University Hospital
Staten Island, New York, 10309
University Community Hospital
Tampa, Florida, 33613
Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615
Cardiology Associates of Fairfield County
Trumbull, Connecticut, 06611
Pima Heart Physicians, PC
Tucson, Arizona, 85712
Trinity Mother Frances Health System
Tyler, Texas, 75701
Wheeling Hospital Inc.
Wheeling, West Virginia, 26003
Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

Germany4 sites

Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
Chemnitz, 09116
Uniklinik Köln
Cologne, 50931
Universitätsklinikum Erlangen
Erlangen, 91054
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, 39120

Other trials in Germany

Spain4 sites

Hospital Clinico Y Provincial
Barcelona, 08036
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital Doctor Peset
Valencia, 46017
Clinico de Valladolid
Valladolid, 47012

Other trials in Spain

Austria3 sites

Medizinische Univ.-Kliniken Graz
Graz, 8036
AKH Linz
Linz, 4021
Klinikum Wels-Grieskirchen GmbH
Wels, 4600

Other trials in Austria

Canada3 sites

Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W IT7
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7

Other trials in Canada

United Kingdom3 sites

Basildon and Thurrock University Hospitals NHS
Basildon, Essex, SS16 5NL
Belfast City Hospital
Belfast, BT9 7
Wrexham Maelor Hospital
Wrexham, LL13 7TD

Other trials in United Kingdom

Australia2 sites

St. Andrew's War Memorial Hospital
Brisbane, Queensland, 4001
The Prince Charles Hospital
Chermside, Queensland, 4032

Other trials in Australia

Belgium2 sites

Universitair Ziekenhuis Gent
Ghent, 9000
AZ Groeninge Campus
Kortrijk, 8500

Other trials in Belgium

Denmark2 sites

Skejby Sygehus
Aarhus, 8200
Roskilde University Hospital
Roskilde, 4000

Other trials in Denmark

France2 sites

CHU La Timone Hospital
Marseille, 13005
NCN Nouvelles Cliniques Nantaises
Nantes, 44277

Other trials in France

Malaysia2 sites

Institut Jantung Negara
Kuala Lumpur, 50400
University of Malaya Medical Centre
Kuala Lumpur, 50603

Other trials in Malaysia

Portugal2 sites

Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, 4099 - 001
Hospital de Santarem
Santarém, 2005-177

Other trials in Portugal

Sweden2 sites

Sahlgrenska University Hospital
Gothenburg, 41345
Karolinska University Hospital
Stockholm

Other trials in Sweden

Hong Kong1 site

Prince of Wales Hospital
Shatin, 999077

Other trials in Hong Kong

Italy1 site

Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126

Other trials in Italy

Thailand1 site

Chiang Mai Heart Center Medical School Hospital
Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: 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.

Read the detailed description

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
Being tested: INGEVITY lead
Keywords: bradycardia, sinus node dysfunction
Medical subject headings: Bradycardia, Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INGEVITY leadDevice

Study groups in NCT01688843
Study group	Role	What they receive
INGEVITY lead	Experimental	INGEVITY lead implant Receives: Device: INGEVITY lead

What is being measured

The primary outcome is the main question the study is designed to answer.

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%
Measured: 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%.
Measured: 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.
Measured: 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
Measured: Lead implant through 3 month follow up
Effectiveness 2(Right Atrium)
P-wave sensed amplitude at three months post-implant > 1.5 mV
Measured: Lead implant through 3 month follow up
Effectiveness 2(Right Ventricle)
R-wave sensed amplitude at three months post-implant > 5 mV
Measured: Lead implant through 3 month follow up
Effectiveness 3
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
Measured: Lead implant through 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Feb 2019

First posted20 Sep 2012 (estimated)
Study startOct 2012
Primary completionJan 2015
Study completionFeb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BradycardiaStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,060 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688843
Sponsor's protocol ID: BSC-CDM00048360
Status last verified: Mar 2020
First submitted: 17 Sep 2012
Last updated: 10 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
ClinicalTrials.gov ID: NCT01688843
Acronym / sponsor ID: BSC-CDM00048360
Conditions: Bradycardia, Sinus Node Dysfunction
Keywords: bradycardia, sinus node dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,060 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jan 2015 (actual)
Study completion: Feb 2019 (actual)
First posted: 20 Sep 2012 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INGEVITY lead	Experimental	Device: INGEVITY leadINGEVITY lead implant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INGEVITY lead	Device	INGEVITY lead

Primary outcome

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%
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%.
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.
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
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
Effectiveness 2(Right Ventricle)
Time frame: Lead implant through 3 month follow up
R-wave sensed amplitude at three months post-implant > 5 mV
Effectiveness 3
Time frame: Lead implant through 3 month follow up
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INGEVITY Study Participants	1,060	1,060

Primary outcome: Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)

Time frame: Lead implant through 3 month follow up. Number (95% Confidence Interval). Unit: percentage of leads complication-free

Measure	INGEVITY Lead n = 1036
Value	98.4 (97.7 to NA)

Population analysed: Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.

Primary outcome: Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)

Time frame: 3 months through 12 months post implant. Number (95% Confidence Interval). Unit: percentage of leads complication-free

Measure	INGEVITY Lead n = 1009
Value	99.7 (99.4 to NA)

Population analysed: Leads still in service and implanted in actively followed participants at 92 days were included in analysis.

Primary outcome: Safety 3 - Hazard Rate of Lead-Related Complications

Time frame: Implant through 12 months (including available data beyond 12 months). Number (95% Confidence Interval). Unit: hazard rate of lead-related complication

Measure	INGEVITY Lead n = 1036
Value	0.23 (NA to 0.3)

Primary outcome: Effectiveness 1

Time frame: Lead implant through 3 month follow up. Mean (95% Confidence Interval). Unit: volts

Measure	INGEVITY Lead n = 982
Value	0.67 (0.65 to 0.69)

Adverse events

Time frame: Entire follow-up (median participant follow-up = 30.9 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INGEVITY Study Participants	532 of 1,041 (51.1%)	621 of 1,041 (59.7%)	93 of 1,060

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bradycardia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles Love, MD principal investigator

Johns Hopkins University

78 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing INGEVITY lead in people with Bradycardia and Sinus Node Dysfunction, run by Boston Scientific Corporation at 78 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Germany, Spain, Austria, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) (time frame: Lead implant through 3 month follow up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01688843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.