BradycardiaNCT04346537

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

An observational study of Bradycardia, run by Boston Scientific Corporation at 13 sites in United States.

Completed

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

Trial summary

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia
What is being tested?: INGEVITY+™ Pace/Sense Lead
Type of treatment: Medical device
How many people: 109 participants
Where: 13 sitesUnited States
Study dates: 6 Aug 2020to 1 Mar 2021
Phase: Observational
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

Study population: Subjects will be selected from the investigator's general patient population indicated for dual-chamber pacemaker or CRT-P implantation.

Who may be able to join

Subject is willing and capable of providing informed consent
Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
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
Age 18 or above, or of legal age to give informed consent specific to state and national law

Who cannot join

Known or suspected sensitivity to dexamethasone acetate (DXA)
Has a mechanical tricuspid heart valve
Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
Currently requiring hemo- or peritoneal dialysis
Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
Intended to receive a single chamber device

Show all 10Show fewer

Documented history of permanent or persistent AF
Currently on an active organ transplant list
Documented life expectancy of less than 12 months
Enrolled in any other concurrent study unless prior approval is received from the Sponsor

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Emory University Hospital
Atlanta, Georgia, 30322
PeaceHealth Southwest Medical
Bellingham, Washington, 98664
Deborah Heart and Lung
Browns Mills, New Jersey, 08015
Aultman Hospital
Canton, Ohio, 44710
Cardiovascular Institute of Michigan
Clinton Township, Michigan, 48048
Heart Center Research, LLC
Huntsville, Alabama, 35801
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Catholic Medical Center
Manchester, New Hampshire, 03102
Saint Thomas Health
Nashville, Tennessee, 37205
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Cox Health
Springfield, Missouri, 65807
Torrance Memorial Medical Center
Torrance, California, 90505

Other trials in United States

About this study

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Conditions: Bradycardia
Being tested: INGEVITY+™ Pace/Sense Lead
Medical subject headings: Bradycardia

What participants receive

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

INGEVITY+™ Pace/Sense LeadDevice
The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.

What is being measured

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

Primary Safety: Lead-related Complication-Free Rate
This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %.
Measured: Lead Implant through 3-Months Post-Implant
Primary Efficacy: Pacing Capture Threshold Responder Rate
This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used.
Measured: At 3-Months Post-Implant

Secondary outcomes (3)

Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)
This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for atrial leads was > 1.5 mV.
Measured: At 3-Months Post-Implant
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)
This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for ventricular leads was > 1.5 mV.
Measured: At 3-Months Post-Implant
Secondary Efficacy: Pacing Impedance in Ohms
This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms.
Measured: At 3-Months Post-Implant

Timeline

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

6 Aug 20201 Mar 2021

First posted15 Apr 2020
Study start6 Aug 2020
Primary completion1 Mar 2021
Study completion1 Mar 2021

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04346537
Sponsor's protocol ID: 92424682
Status last verified: Jul 2022
First submitted: 8 Apr 2020
Last updated: 14 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia

All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
ClinicalTrials.gov ID: NCT04346537
Acronym / sponsor ID: 92424682
Conditions: Bradycardia
Study type: Observational
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 6 Aug 2020 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Mar 2021 (actual)
First posted: 15 Apr 2020 (actual)
Results: Posted 12 May 2022

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 it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects will be selected from the investigator's general patient population indicated for dual-chamber pacemaker or CRT-P implantation.

Key inclusion criteria (5 listed)

Subject is willing and capable of providing informed consent
Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
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
Age 18 or above, or of legal age to give informed consent specific to state and national law

Key exclusion criteria (10 listed)

Known or suspected sensitivity to dexamethasone acetate (DXA)
Has a mechanical tricuspid heart valve
Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
Currently requiring hemo- or peritoneal dialysis
Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems

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+™ Pace/Sense LeadThe INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.	Device	–

Primary outcome

Primary Safety: Lead-related Complication-Free Rate
Time frame: Lead Implant through 3-Months Post-Implant
This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %.
Primary Efficacy: Pacing Capture Threshold Responder Rate
Time frame: At 3-Months Post-Implant
This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used.

3 secondary outcomes

Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)
Time frame: At 3-Months Post-Implant
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)
Time frame: At 3-Months Post-Implant
Secondary Efficacy: Pacing Impedance in Ohms
Time frame: At 3-Months Post-Implant

Results and safety

Results posted to the registry on 12 May 2022, 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	109	99

Primary outcome: Primary Safety: Lead-related Complication-Free Rate

Time frame: Lead Implant through 3-Months Post-Implant. Number (97.5% Confidence Interval). Unit: Percentage of leads

Measure	INGEVITY+ Leads n = 101
Value	98.5 (95.4 to NA)

Primary outcome: Primary Efficacy: Pacing Capture Threshold Responder Rate

Time frame: At 3-Months Post-Implant. Number (95% Confidence Interval). Unit: Percentage of leads

Measure	INGEVITY+ Leads n = 98
Value	98.9 (96.2 to 99.9)

Population analysed: Of the 201 leads eligible for endpoint analysis, 15 did not contribute to data the analysis (1 had unsuccessful lead implant, 14 had missing 3 month data due to death/withdrawal prior to 3-month visit, missed 3-month visit or incomplete lead measurement data).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Implant through 3-months post-implant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INGEVITY+ Study Participants	8 of 101 (7.9%)	10 of 101 (9.9%)	1 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bradycardia

RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia

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.

Devi Nair, MD principal investigator

Arrhythmia Research Group

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bradycardia, run by Boston Scientific Corporation at 13 sites in United States.

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 5 inclusion and 10 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 12 May 2022). 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?

Primary Safety: Lead-related Complication-Free Rate (time frame: Lead Implant through 3-Months Post-Implant). The study lists 2 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 NCT04346537.

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 14 Jul 2022.