NCT03398369 · University of Virginia
Mechanistic Clinical Trial of Advanced Imaging for CRT
What this study is about
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.
View original scientific description
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Chronic systolic HF
- LVEF 35% or less
- Guideline-based class I or II indication for CRT
Exclusion criteria
- Inability to provide informed consent
- Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
- Cerebral aneurysm clips
- Cochlear implants
- Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
- Severe claustrophobia
- Acute kidney injury
- Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2
- Liver transplant
- Gadolinium allergy
- \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.
Where
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2020 · Source of record for eligibility and locations