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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has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

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.

02

Conditions studied

  • Heart Failure, Systolic
03

Who can participate

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide informed consent
  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 contraindications to CMR (does not include pacemakers and ICDs)
  7. Severe claustrophobia
  8. Acute kidney injury
  9. Acute renal failure or chronic kidney disease with GFR \< 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.
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03398369
Lead sponsor
University of Virginia
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.

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