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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: Completed study of Bradycardia and Arrhythmia, sponsored by Medtronic.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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
Medtronic

30 total trials

What the finished NCT01076374 record still lists

NCT01076374 is an observational study that tracks outcomes without assigning an intervention. Its 2,927 participants enrollment target places it among the larger protocols in the corpus, below the 4,312-participant average among 29 other Bradycardia trials with a reported enrollment target (32% lower).

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

NCT01076374 names 20 study sites across 6 states, led by 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.

Similar trials for Bradycardia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01076374's enrollment target sits among peer trials

2,927 7th of 29 higher than 23 of 29 other Bradycardia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bradycardia 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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Source: ClinicalTrials.gov NCT01076374, the US trial registry maintained by the National Library of Medicine. NCT01076374 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.