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CompletedNCT04346537Updated Jul 14, 2022Results posted

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

An observational study in Bradycardia, sponsored by Boston Scientific Corporation. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Bradycardia

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03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's enrollment of 109 is below the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Subject is willing and capable of providing informed consent
  2. 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
  3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
  4. 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
  5. Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected sensitivity to dexamethasone acetate (DXA)
  2. Has a mechanical tricuspid heart valve
  3. 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)
  4. Currently requiring hemo- or peritoneal dialysis
  5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
  6. Intended to receive a single chamber device
  7. Documented history of permanent or persistent AF
  8. Currently on an active organ transplant list
  9. Documented life expectancy of less than 12 months
  10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (actual)
Patient registry
No

Interventions

  • DeviceINGEVITY+™ Pace/Sense Lead

    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.

06

What researchers measure

Primary outcomes

  1. 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 %.

    Time frame: Lead Implant through 3-Months Post-Implant

  2. 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.

    Time frame: At 3-Months Post-Implant

Secondary outcomes

  1. 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.

    Time frame: At 3-Months Post-Implant

  2. 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.

    Time frame: At 3-Months Post-Implant

  3. 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.

    Time frame: At 3-Months Post-Implant

07

Results

Posted May 12, 2022

Participant flow

Participant flow — Overall Study
MilestoneINGEVITY+ Study Participants
Started109
Implanted/attempted with ingevity+ lead101
Completed99
Not completed10

Outcome measures

PrimaryPrimary 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 %.

Time frame:
Lead Implant through 3-Months Post-Implant
Reported as:
Number · Percentage of leads
Primary Safety: Lead-related Complication-Free Rate
Percentage of leadsINGEVITY+ Leads
Primary Safety: Lead-related Complication-Free Rate98.5 (95.4 to NA)
PrimaryPrimary 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.

Time frame:
At 3-Months Post-Implant
Reported as:
Number · Percentage of leads
Primary Efficacy: Pacing Capture Threshold Responder Rate
Percentage of leadsINGEVITY+ Leads
Primary Efficacy: Pacing Capture Threshold Responder Rate98.9 (96.2 to 99.9)
SecondarySecondary 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.

Time frame:
At 3-Months Post-Implant
Reported as:
Median · millivolts
Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)
millivoltsINGEVITY+ Leads
Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)4.3 (2.4 to 6.2)
Statistical analysis
  • INGEVITY+ Leads · Wilcoxon signed rank test · p = < 0.001
SecondarySecondary 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.

Time frame:
At 3-Months Post-Implant
Reported as:
Median · millivolts
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)
millivoltsINGEVITY+ Leads
Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)15.9 (10.5 to 24.0)
Statistical analysis
  • INGEVITY+ Leads · Wilcoxon signed rank test · p = < 0.001
SecondarySecondary 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.

Time frame:
At 3-Months Post-Implant
Reported as:
Mean · ohms
Secondary Efficacy: Pacing Impedance in Ohms
ohmsINGEVITY+ Leads
Secondary Efficacy: Pacing Impedance in Ohms712 (696 to 729)
Statistical analysis
  • INGEVITY+ Leads · Two one-sided t-tests · p = < 0.001

Adverse events

Collected over Implant through 3-months post-implant.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
INGEVITY+ Study Participants1/101 (1%)8/101 (7.9%)10/101 (9.9%)
Most frequent serious events
Most frequent serious events
EventINGEVITY+ Study Participants
Dislodgment - related to right atrial leadProduct Issues1/101
Myocardial perforation post-implant - related right atrial leadProduct Issues1/101
HemothoraxSurgical and medical procedures1/101
Post-surgical infection (<=30 days post-implant)Surgical and medical procedures1/101
Atrial fibrillationCardiac disorders1/101
Chest painCardiac disorders1/101
DeathGeneral disorders1/101
DiverticulitisGastrointestinal disorders1/101
Systemic infectionInfections and infestations1/101
Most frequent other events
Most frequent other events
EventINGEVITY+ Study Participants
Atrial fibrillationCardiac disorders3/101
Adverse reactionSurgical and medical procedures2/101
Sensation of pacing with auto threshold - related to pulse generatorProduct Issues1/101
Dislodgment - related to right atrial leadProduct Issues1/101
Dislodgment - related to right ventricular leadProduct Issues1/101
Chest painSurgical and medical procedures1/101
Atrial flutterCardiac disorders1/101
Atrial tachycardia/Other supraventricular tachycardiaCardiac disorders1/101
Deep vein thrombosisCardiac disorders1/101

Baseline characteristics

Baseline characteristics are reported on enrolled participants.

Age, Continuous
Age, Continuous(years)INGEVITY+ Study Participants
Mean73.2 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)INGEVITY+ Study Participants
Female51
Male58
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)INGEVITY+ Study Participants
Hispanic or Latino1
Not Hispanic or Latino108
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)INGEVITY+ Study Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American11
White96
More than one race1
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)INGEVITY+ Study Participants
United States109
Brady Arrhythmia History
Brady Arrhythmia History(Participants)INGEVITY+ Study Participants
Sinus Bradycardia72
Sinus Node Dysfunction29
Chronotropic Incompetence7
Sinus Arrest4
Atrioventricular Block - 1st Degree4
Atrioventricular Block - 2nd Degree (Intermittent)5
Atrioventricular Block - 2nd Degree (Permanent)6
Atrioventricular Block - 3rd Degree (Intermittent)2
Atrioventricular Block - 3rd Degree (Permanent)4
08

Study locations

13 sites
  • Heart Center Research, LLC
    Huntsville, Alabama 35801, United States
  • Arrhythmia Research Group
    Jonesboro, Arkansas 72401, United States
  • Torrance Memorial Medical Center
    Torrance, California 90505, United States
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Cardiovascular Institute of Michigan
    Clinton Township, Michigan 48048, United States
  • Cox Health
    Springfield, Missouri 65807, United States
  • Catholic Medical Center
    Manchester, New Hampshire 03102, United States
  • Deborah Heart and Lung
    Browns Mills, New Jersey 08015, United States
  • Aultman Hospital
    Canton, Ohio 44710, United States
  • Saint Thomas Health
    Nashville, Tennessee 37205, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • PeaceHealth Southwest Medical
    Bellingham, Washington 98664, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04346537
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Apr 15, 2020
Start date
Aug 6, 2020
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Results posted
May 12, 2022
Last update
Jul 14, 2022

Study contacts

Devi Nair, MD
principal investigator · Arrhythmia Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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