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NCT00982397 · ClinicalTrials.gov registry record · NA
Safety and Clinical Performance of the Protecta ICD and CRT-D
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 2,770
- Enrollment target
NCT00982397: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00982397 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 2,770 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00982397, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,770 participants
- Enrollment target
Study Summary
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.
Primary Outcome
Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
Interventions
- DEVICE Protecta VR-ICD
- DEVICE Protecta DR-ICD or CRT-D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,770 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-09 |
| Phase | NA |
What the finished NCT00982397 record still lists
NCT00982397 is an interventional study that assigns participants to a tested intervention. Its 2,770 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 2 interventions - of which Protecta VR-ICD is the first listed.
NCT00982397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00982397 about?
NCT00982397 is a clinical study titled "Safety and Clinical Performance of the Protecta ICD and CRT-D". The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynch...
What is the current status of trial NCT00982397?
This trial is currently completed. It is a NA study. The enrollment target is 2,770 participants. The study started on 2009-09. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00982397?
The interventions under investigation include: Protecta VR-ICD (DEVICE), Protecta DR-ICD or CRT-D (DEVICE).
Who is sponsoring clinical trial NCT00982397?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00982397's enrollment target sits among peer trials
2,770 44th of 2000 higher than 1,957 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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