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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475175

Enrollment

Registered

2011-11-21

Start date

2011-11-30

Completion date

2012-03-31

Last updated

2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICECRT pacing at rest and during exercise

CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Stroke Volume at Rest	Test day visit (within 14 days of enrollment)	Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.
Stroke Volume During Atrial Pacing.	Test day visit (within 14 days of enrollment)	Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.
Stroke Volume During Sub-maximal Exercise.	Test day visit (within 14 days of enrollment)	Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.

Secondary

Measure	Time frame	Description
Cardiac Function With Nominal Settings During Sub-maximal Exercise.	Test day visit (within 14 days of enrollment)	Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
Cardiac Function With aCRT Settings at Rest	Test day visit (within 14 days of enrollment)	Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.
Electrical Conduction During Sub-maximal Exercise.	Time Frame: Test day visit (within 14 days of enrollment)	Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.
Electrical Conduction at Rest.	Test day visit (within 14 days of enrollment)	Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.
Cardiac Function With Nominal Settings at Rest.	Test day visit (within 14 days of enrollment)	Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
Cardiac Function With aCRT Settings During Sub-maximal Exercise.	Test day visit (within 14 days of enrollment)	Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.

Countries

Austria, Belgium, Denmark, Germany, Netherlands, Norway

Participant flow

Recruitment details

Twelve subjects were enrolled at six centers in Europe between November 2011 and March 2012.

Participants by arm

Arm	Count
Adaptive CRT Pacing Cardiac resynchronization therapy (CRT) with adaptive pacing.	12
Total	12

Baseline characteristics

Characteristic	Adaptive CRT Pacing
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	7 Participants
Age, Categorical Between 18 and 65 years	5 Participants
Age, Continuous	64.3 years STANDARD_DEVIATION 16.8
Region of Enrollment Austria	2 participants
Region of Enrollment Belgium	2 participants
Region of Enrollment Denmark	1 participants
Region of Enrollment Germany	2 participants
Region of Enrollment Netherlands	3 participants
Region of Enrollment Norway	2 participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 12
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

Stroke Volume at Rest

Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.