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NCT01076374 · ClinicalTrials.gov registry record

MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

A clinical trial of Bradycardia and Arrhythmia, sponsored by Medtronic.

Completed
Registry status
2,927
Enrollment target
20
Study locations

NCT01076374 is a study of Bradycardia and Arrhythmia that has completed, run by Medtronic. The registered enrollment target is 2,927 participants, below the 4,312-participant average among 29 other Bradycardia trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT01076374, a study of Bradycardia and Arrhythmia, has completed, sponsored by Medtronic.

COMPLETED
Registry status
2,927 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

Conditions Studied

Bradycardia Arrhythmia

Study Locations (20)

California

  • - Bakersfield
  • - Chula Vista
  • - Downey
  • - East Palo Alto
  • - La Jolla
  • - Long Beach
  • - Los Angeles
  • - Redding
  • - Salinas
  • - San Diego
  • - Santa Rosa
  • - Torrance
  • - Van Nuys

Arizona

  • - Gilbert
  • - Scottsdale

Arkansas

  • - Jonesboro
  • - Little Rock

Alabama

  • - Birmingham

Alaska

  • - Anchorage

Colorado

  • - Colorado Springs

Trial Details

FieldValue
Enrollment Target 2,927 participants
Start Date 2008-07
Est. Completion 2015-12

Sponsor

Medtronic

30 total trials

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What the Registry Record Tells You About NCT01076374

The ClinicalTrials.gov registry entry for NCT01076374 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,927 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,312-participant average among 29 other Bradycardia trials with a reported enrollment target (32% lower). The listed sponsor is Medtronic, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bradycardia appearing as the primary indexed condition, and to 0 interventions.

NCT01076374 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01076374 about?

NCT01076374 is a clinical study titled "MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY". The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from...

What is the current status of trial NCT01076374?

This trial is currently completed. The enrollment target is 2,927 participants. The study started on 2008-07. Estimated completion is 2015-12.

What conditions does trial NCT01076374 study?

This clinical trial studies the following conditions: Bradycardia, Arrhythmia.

Who is sponsoring clinical trial NCT01076374?

This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01076374 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.