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Compares treatment options for Heart Failure
Official title Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
ClinicalTrials.gov ID: NCT05532631
What this study is testing
- What it's testing
- A short description, 5000 characters Ischemic cardiomyopathy related to coronary artery disease is currently the leading cause of heart failure. When it is responsible for heart failure, the coronary artery disease likely involves 2 or 3 vessels.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission...
- Multivessel disease suitable for revascularization:
- Three vessel disease
- Two vessel disease involving left main or proximal left anterior descending artery
You likely can't join if
- Prior:
- PCI of any coronary artery lesions within 6 months prior to randomization
- CABG at any time prior to randomization
- Ongoing cardiogenic shock at the time of coronary angiogram (SBP\< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
- Contra indication for PCI or CABG determined by the heart team
- Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed
See the full eligibility criteria
- Age ≥18 years
- Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram
- Multivessel disease suitable for revascularization:
- Three vessel disease
- Two vessel disease involving left main or proximal left anterior descending artery
- Clinical and anatomic eligibility for both percutaneous coronary intervention (PCI) and Coronary artery bypass grafting (CABG) as agreed to by the local Heart Team (interventionalist determines PCI appropriateness and...
- Ability to sign informed consent and comply with all study procedures, including follow-up for at least two years
- Affiliation to health insurance
- Prior:
- PCI of any coronary artery lesions within 6 months prior to randomization
- CABG at any time prior to randomization
- Ongoing cardiogenic shock at the time of coronary angiogram (SBP\< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
- Contra indication for PCI or CABG determined by the heart team
- Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed
- ST elevation myocardial infarction \< 30 days
- Non-cardiac illness with a life expectancy of less than 24 months
- Current participation in other investigational drug or device studies
- Women who are pregnant or nursing
- Females of childbearing potential without effective method of birth control
- Patients who are under tutorship or curatorship
- Patient on AME (state medical aid)
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, Val De Marne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, Val De Marne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.