Clinical trial NCT01475175: Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
Official title: Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Eligibility criteria: 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 of study enrollment

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stroke Volume at Rest
timeFrame: Test day visit (within 14 days of enrollment)
measure: Stroke Volume During Atrial Pacing.
timeFrame: Test day visit (within 14 days of enrollment)
measure: Stroke Volume During Sub-maximal Exercise.
timeFrame: Test day visit (within 14 days of enrollment)
Secondary outcomes:
measure: Cardiac Function With aCRT Settings at Rest
timeFrame: Test day visit (within 14 days of enrollment)
measure: Cardiac Function With Nominal Settings at Rest.
timeFrame: Test day visit (within 14 days of enrollment)
measure: Cardiac Function With aCRT Settings During Sub-maximal Exercise.
timeFrame: Test day visit (within 14 days of enrollment)
measure: Cardiac Function With Nominal Settings During Sub-maximal Exercise.
timeFrame: Test day visit (within 14 days of enrollment)
measure: Electrical Conduction at Rest.
timeFrame: Test day visit (within 14 days of enrollment)
measure: Electrical Conduction During Sub-maximal Exercise.
timeFrame: Time Frame: Test day visit (within 14 days of enrollment)
Other outcomes:
Locations:
city: Linz
country: Austria
city: Genk
country: Belgium
city: Leuven
country: Belgium
city: Arhus
country: Denmark
city: Ludenscheid
country: Germany
city: Nijmegen
country: Netherlands
city: Oslo
country: Norway
Study officials:
affiliation: Medtronic
name: AdOPT CRT/aCRT Study Team
role: STUDY_CHAIR
References: