Status:
TERMINATED
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
Eligibility Criteria
Inclusion
- 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 of study enrollment
Exclusion
- Subject has a history of persistent or permanent AF for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
- Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy 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 study enrollment
- 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 pregnancy test 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 this study.
- Subject meets exclusion criteria required by local law
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01475175
Start Date
November 1 2011
End Date
March 1 2012
Last Update
August 5 2019
Active Locations (7)
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1
Linz, Austria
2
Genk, Belgium
3
Leuven, Belgium
4
Aarhus, Denmark