CardiomyopathyDevise-CRTNCT00737490

Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)

A study testing "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343) and "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343) in people with Cardiomyopathy and Heart Failure, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiomyopathy, Heart Failure
What is being tested?: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343) and "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jun 2005to Jul 2011
Phase: Interventional
Are there results?: None posted in the registry

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

LVEF </= 35% as assessed by echocardiography.
New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
QRS duration of >/= 120 ms.
Ability to provide written, informed consent.
Age > 18 years.
Successful implant of a biventricular/ICD pacemaker device.

Who cannot join

Documented Chronic Atrial Fibrillation
Life expectancy less that 6 months due to non-cardiac causes
Inability to place a coronary sinus left ventricular pacing lead
Pregnancy
Scheduled cardiac surgery within the next 6 months
Prosthetic Tricuspid Valve

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.

Conditions: Cardiomyopathy, Heart Failure
Being tested: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343), "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
Medical subject headings: Cardiomyopathies, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)Other
Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"
Using one of the FDA approved St. Jude devices, depending on MD preference.
"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)Other
simultaneous BiV pacing.
Using one of the FDA approved St. Jude devices, depending on MD preference.

Study groups in NCT00737490
Study group	Role	What they receive
1	Active comparator	Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm" Receives: Other: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)
2	Active comparator	Simultaneous BiV pacing. "Simultaneous Arm" Receives: Other: "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced.
Measured: 6 months

Secondary outcomes (1)

Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jul 2011

First posted19 Aug 2008 (estimated)
Study startJun 2005
Primary completionDec 2009
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CardiomyopathyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737490
Sponsor's protocol ID: Pro00007865
Other IDs: 7314
Acronym: Devise-CRT
Status last verified: Apr 2013
First submitted: 4 May 2008
Last updated: 1 Aug 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)
ClinicalTrials.gov ID: NCT00737490
Acronym / sponsor ID: Devise-CRT / Pro00007865
Conditions: Cardiomyopathy, Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Abbott Medical Devices
Study start: Jun 2005
Primary completion: Dec 2009 (actual)
Study completion: Jul 2011 (actual)
First posted: 19 Aug 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Other: "Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"
2	Active comparator	Other: "Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)Simultaneous BiV pacing. "Simultaneous Arm"

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

LVEF </= 35% as assessed by echocardiography.
New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
QRS duration of >/= 120 ms.
Ability to provide written, informed consent.
Age > 18 years.

Key exclusion criteria (6 listed)

Documented Chronic Atrial Fibrillation
Life expectancy less that 6 months due to non-cardiac causes
Inability to place a coronary sinus left ventricular pacing lead
Pregnancy
Scheduled cardiac surgery within the next 6 months

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
"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm" Using one of the FDA approved St. Jude devices, depending on MD preference.	Other	1
"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)simultaneous BiV pacing. Using one of the FDA approved St. Jude devices, depending on MD preference.	Other	2

Primary outcome

To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced.
Time frame: 6 months

1 secondary outcome

Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.

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Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
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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.

Hranitzky Patrick, MD principal investigator

Duke University

Patrick Hranitzky, MD study director

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737490.

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 1 Aug 2014.