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NCT04346537 · ClinicalTrials.gov registry record
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 109
- Enrollment target
NCT04346537: Completed study, sponsored by Boston Scientific Corporation.
NCT04346537 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 109 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04346537 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 109 participants
- Enrollment target
Study Summary
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
Primary Outcome
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 %.
Interventions
- DEVICE INGEVITY+™ Pace/Sense Lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2021-03-01 |
What the finished NCT04346537 record still lists
NCT04346537 is an observational study that tracks outcomes without assigning an intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which INGEVITY+™ Pace/Sense Lead is the first listed.
NCT04346537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04346537 about?
NCT04346537 is a clinical study titled "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.
What is the current status of trial NCT04346537?
This trial is currently completed. The enrollment target is 109 participants. The study started on 2020-08-06. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT04346537?
The interventions under investigation include: INGEVITY+™ Pace/Sense Lead (DEVICE).
Who is sponsoring clinical trial NCT04346537?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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