Cardiac Resynchronization Therapy Efficacy Enhancements

Last updated: November 8, 2016
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT02222818
CRTee
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is willing to sign and date the study patient Informed Consent form.

  • Subject is at least 18 years of age (or older, if required by local law).

  • Subject is expected to remain available after enrollment to complete follow-up visitsin both arms of the study

  • Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 daysprior to enrollment.

  • Subject has history of AF burden, of at least 6 days of at least 4 hours of AF overany 4 week period within the last 90 days as documented in device diagnostic data ORif subject has no atrial lead (therefore no device diagnostic data) but clinicalevidence of high AF burden.

  • Subject has demonstrated history of being able to complete Left Ventricular CaptureManagement (LVCM) documented in device data.

  • Subject has a documented % V pacing during AF of less than or equal to 97% within 90days prior to enrollment or within 10 days after enrollment.

Exclusion

Exclusion Criteria:

  • Subject has undergone AV node ablation for treatment of AF.

  • Subject has complete or 3rd degree AV block.

  • Subject has had an MI within 30 days.

  • Subject has medical conditions that limit study participation (per physiciandiscretion).

  • Subject is enrolled in one or more concurrent studies that could confound the studyresults as determined by Medtronic.

  • Subject has a limited life expectancy for non-cardiac causes that would not allowcompletion of the study.

  • Subject is pregnant (in the US, all women of child-bearing potential must undergo apregnancy test within seven days prior to CRTee download).

  • Subject meets the exclusion criteria required by local law.

Study Design

Total Participants: 71
Study Start date:
October 01, 2014
Estimated Completion Date:
January 31, 2016

Study Description

The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).

Connect with a study center

  • Magyar Honvédség Honvédkorház

    Budapest,
    Hungary

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini

    Seriate,
    Italy

    Site Not Available

  • Azienda Ospedaliera Cardinale Panico

    Tricase,
    Italy

    Site Not Available

  • Prince Sultan Cardiac Center

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

    Kosice,
    Slovakia

    Site Not Available

  • Mediclinic Panorama

    Cape Town,
    South Africa

    Site Not Available

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Cardiac Arrythmia Services

    Boca Raton, Florida
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa
    United States

    Site Not Available

  • North Memorial Heart and Vascular

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Medtronic, Inc

    Mounds View, Minnesota 55118
    United States

    Site Not Available

  • CentraCare

    St. Cloud, Minnesota
    United States

    Site Not Available

  • North Carolina Heart and Vascular

    Raleigh, North Carolina
    United States

    Site Not Available

  • Mount Carmel

    Columbus, Ohio
    United States

    Site Not Available

  • Oklahoma Heart

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Berks Cardiology

    Reading, Pennsylvania
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Services

    Austin, Texas 78705
    United States

    Site Not Available

  • Kootenai Heart Clinics

    Spokane, Washington
    United States

    Site Not Available

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