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Completed

NCT Number: NCT04346537

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

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

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research, LLC, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

INGEVITY+™ Pace/Sense Lead

Device

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.

Primary outcomes

  1. 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 %.

  2. 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.

Secondary outcomes

  1. Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)

    Time frame: At 3-Months Post-Implant

    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.

  2. Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)

    Time frame: At 3-Months Post-Implant

    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.

  3. Secondary Efficacy: Pacing Impedance in Ohms

    Time frame: At 3-Months Post-Implant

    This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2020
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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