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MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

NCT01076374 · View on ClinicalTrials.gov ↗

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

Sponsor

Medtronic

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01076374

The ClinicalTrials.gov registry entry for NCT01076374 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,927 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bradycardia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01076374 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01076374?

This trial is sponsored by Medtronic, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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