Heart FailureNCT01475175
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
A study testing CRT pacing at rest and during exercise in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT pacing at rest and during exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Nov 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
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.
Read the detailed description
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
- Conditions
- Heart Failure
- Being tested
- CRT pacing at rest and during exercise
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT pacing at rest and during exerciseDevice
CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise
| Study group | Role | What they receive |
|---|---|---|
| CRT pacing at rest and during exercise | Experimental | Rest and sub-maximal exercise Receives: Device: CRT pacing at rest and during exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test day visit (within 14 days of enrollment)
Stroke Volume During Atrial Pacing.
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.
Measured: Test day visit (within 14 days of enrollment)
Stroke Volume During Sub-maximal Exercise.
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.
Measured: Test day visit (within 14 days of enrollment)
Secondary outcomes (6)
Cardiac Function With aCRT Settings at Rest
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.
Measured: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings at Rest.
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
Measured: Test day visit (within 14 days of enrollment)
Cardiac Function With aCRT Settings During Sub-maximal Exercise.
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.
Measured: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings During Sub-maximal Exercise.
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
Measured: Test day visit (within 14 days of enrollment)
Electrical Conduction at Rest.
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.
Measured: Test day visit (within 14 days of enrollment)
Electrical Conduction During Sub-maximal Exercise.
Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.
Measured: Time Frame: Test day visit (within 14 days of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Unable to reach sample size to satisfy the primary objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AdOPT CRT/aCRT Study Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475175
- Sponsor's protocol ID
- AdOPT CRT Sub Study
- Status last verified
- Jun 2019
- First submitted
- 16 Nov 2011
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
- ClinicalTrials.gov ID
- NCT01475175
- Acronym / sponsor ID
- AdOPT CRT Sub Study
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach sample size to satisfy the primary objective
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Nov 2011 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT pacing at rest and during exercise | Experimental | Device: CRT pacing at rest and during exerciseRest and sub-maximal exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT pacing at rest and during exerciseCRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise | Device | CRT pacing at rest and during exercise |
Primary outcome
Stroke Volume at Rest
Time frame: 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.
Time frame: 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.
Time frame: 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.
6 secondary outcomes
Cardiac Function With aCRT Settings at Rest
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings at Rest.
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With aCRT Settings During Sub-maximal Exercise.
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings During Sub-maximal Exercise.
Time frame: Test day visit (within 14 days of enrollment)
Electrical Conduction at Rest.
Time frame: Test day visit (within 14 days of enrollment)
Electrical Conduction During Sub-maximal Exercise.
Time frame: Time Frame: Test day visit (within 14 days of enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AdOPT CRT/aCRT Study Team study chair
Medtronic
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT pacing at rest and during exercise in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Austria, Denmark, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Volume at Rest (time frame: Test day visit (within 14 days of enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.