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NCT01751022 · ClinicalTrials.gov registry record · NA
Attain Performa(TM) Quadripolar Lead Study
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 1,202
- Enrollment target
NCT01751022: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01751022 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 1,202 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751022, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,202 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
Primary Outcome
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: \- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%). \- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be ch
Interventions
- DEVICE Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,202 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT01751022 record still lists
NCT01751022 is an interventional study that assigns participants to a tested intervention. Its 1,202 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 1 intervention - of which Device: Attain Performa Pacing Lead (along with a standard CRT-D system) is the first listed.
NCT01751022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751022 about?
NCT01751022 is a clinical study titled "Attain Performa(TM) Quadripolar Lead Study". The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
What is the current status of trial NCT01751022?
This trial is currently completed. It is a NA study. The enrollment target is 1,202 participants. The study started on 2012-12. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01751022?
The interventions under investigation include: Device: Attain Performa Pacing Lead (along with a standard CRT-D system) (DEVICE).
Who is sponsoring clinical trial NCT01751022?
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 NCT01751022's enrollment target sits among peer trials
1,202 83rd of 2000 higher than 1,918 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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