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INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study | Clinical Trials | Clareo Health

COMPLETED

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

NCT04346537•Boston Scientific Corporation

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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

Locations (13)

Heart Center Research, LLC

Huntsville, Alabama, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Torrance Memorial Medical Center

Torrance, California, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Cardiovascular Institute of Michigan

Clinton Township, Michigan, United States

Cox Health

Springfield, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Deborah Heart and Lung

Browns Mills, New Jersey, United States

Aultman Hospital

Canton, Ohio, United States

Key Dates

Start Date

August 6, 2020

Primary Completion Date

March 1, 2021

Completion Date

March 1, 2021

Last Updated

July 14, 2022

Enrollment

109

ACTUAL participants

Conditions

Bradycardia

Interventions

INGEVITY+™ Pace/Sense Lead

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

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RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291

BradycardiaHeart Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery