Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

Last updated: June 19, 2019
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Terminated

Phase

N/A

Condition

Hyponatremia

Congestive Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01475175
AdOPT CRT Sub Study
  • Ages > 18
  • All Genders

Study Summary

The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is age 18 or greater

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

  • Subject has been implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months from the date ofstudy enrollment

Exclusion

Exclusion Criteria:

  • Subject has a history of persistent or permanent AF for which pharmacological therapyand/or cardioversion have been unsuccessful or have not been attempted.

  • Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricularectopy at the time of enrollment.

  • Subject's resting heart rate at the time of enrollment exceeds 90 bpm.

  • Subject had CRT system implanted for more than 7 months from the date of the studyenrollment

  • Subject has complete AV block.

  • Subject had previous mechanical valve surgeries.

  • Subject has congenital heart disease.

  • Subject has contraindication for an exercise test.

  • Subject is unable to perform a sub-maximal exercise test.

  • It is not possible to acquire technically acceptable echocardiographic images.

  • Subject has medical conditions that would limit study participation.

  • Subject is pregnant (all women of child-bearing potential must undergo a pregnancytest within seven days prior to the study visit).

  • Subject is enrolled in the Adaptive CRT study

  • Subject is enrolled in concurrent studies which could confound the results of thisstudy.

  • Subject meets exclusion criteria required by local law

Study Design

Total Participants: 12
Study Start date:
November 01, 2011
Estimated Completion Date:
March 31, 2012

Study Description

Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.

Connect with a study center

  • Linz,
    Austria

    Site Not Available

  • Genk,
    Belgium

    Site Not Available

  • Leuven,
    Belgium

    Site Not Available

  • Arhus,
    Denmark

    Site Not Available

  • Ludenscheid,
    Germany

    Site Not Available

  • Nijmegen,
    Netherlands

    Site Not Available

  • Oslo,
    Norway

    Site Not Available

  • empty

    Belgrade,
    Serbia

    Site Not Available

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