Mechanistic Clinical Trial of Advanced Imaging for CRT

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    180
  • sponsor
    University of Virginia
Updated on 26 February 2022
angiography
MRI

Summary

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.

Description

At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.

Details
Condition Heart Failure, Systolic
Treatment MRI-Guided CRT, CMR/CTA Guidance for CRT
Clinical Study IdentifierNCT03398369
SponsorUniversity of Virginia
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
Pregnancy
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note