CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,202 enrolled
Drug / intervention
Device: Attain Performa Pacing Lead (along with a standard CRT-D system)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01751022
NCT01751022N/ACompleted
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Attain Performa(TM) Quadripolar Lead Study

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Dec 17, 2012·Updated Dec 5, 2016

In Brief

A clinical study evaluating Device: Attain Performa Pacing Lead (along with a standard CRT-D system) for Heart Failure. Completed, enrolled 1,202 participants across 121 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustralia, Austria, Belgium, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartDec 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.5 years ago

Interventions

Device: Attain Performa Pacing Lead (along with a standard CRT-D system)device

Implant and follow-up of study lead, separate analysis for each lead model