ClinicalTrials.gg
Status unknownNCT03398369Updated Feb 6, 2020

Mechanistic Clinical Trial of Advanced Imaging for CRT

An interventional study of CMR/CTA Guidance for CRT in Heart Failure, Systolic, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by University of Virginia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.

Planned enrollment
16th of 69
180 · median 40
Started
2018
with 9 others
No phase
44 of 83
10 open now
Registered
35th of 83
by date
Lead sponsor
3 of 83
University of Virginia

Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 16th largest by planned enrollment of the 69 interventional ones that give a count, is one of 10 that started in 2018, is one of 44 with no phase, and was the 35th registered.

Heart Failure, Systolic

230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.

Browse Heart Failure, Systolic studies →

Open to participants now

17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.

This study: 20 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 83 studies in Heart Failure, Systolic with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Heart Failure, Systolic
04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chronic systolic HF
  2. 35% or less
  3. Guideline-based class I or II indication for CRT

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide
  2. Pregnancy
  3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
  4. Cerebral aneurysm clips
  5. Cochlear implants
  6. Other metallic implants known to be to CMR (does not include pacemakers and ICDs)
  7. Severe claustrophobia
  8. Acute kidney injury
  9. Acute renal failure or chronic kidney disease with \< 45 cc/min/1.73m2
  10. Liver transplant
  11. Gadolinium allergy
  12. >10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Intervention

    CMR-Guided CRT

    Diagnostic Test: CMR/CTA Guidance for CRT

  • No intervention
    Control

    Standard CRT

Interventions

  • Diagnostic testCMR/CTA Guidance for CRT

    The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.

06

What researchers measure

Primary outcomes

  1. Left ventricular end-systolic volume (LVESV) improvement

    Change in LVESV with cardiac resynchronization therapy (CRT)

    Time frame: One Year

07

Study locations

1 of 1 sites recruiting
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Jan 2025, 84 months after the start.

Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 84 months is above that.

Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2018
First posted
Jan 12, 2018
StartActual
Jan 5, 2018
Primary completionEst.
Jan 15, 2025
CompletionEst.
Jan 15, 2025
Last update
Feb 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398369
Responsible party
Kenneth Bilchick, MD (Associate Professor of Medicine, University of Virginia) — Principal investigator
First posted
Jan 12, 2018
Start date
Jan 5, 2018
Primary completion
Jan 15, 2025 (estimated)
Completion
Jan 15, 2025 (estimated)
Last update
Feb 6, 2020

Study contacts

Kenneth C Bilchick, MD
Contact
bilchick@virginia.edu
4349242465
Hollis Phillips, BA
Contact
hp9r@hscmail.mcc.virginia.edu
434-243-0046
Kenneth C Bilchick, MD
principal investigator · University of Virginia Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion