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Recruiting NCT03398369

Mechanistic Clinical Trial of Advanced Imaging for CRT

No phase Interventional Heart Failure, Systolic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CMR/CTA Guidance for CRT.
Who it may be relevant to
Registry conditions: Heart Failure, Systolic. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT

Overview

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.

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.

Interventions

  • Diagnostic test CMR/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.

Primary outcome measures

  • Left ventricular end-systolic volume (LVESV) improvement [Time frame: One Year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Virginia Health System — Charlottesville

Identifiers

NCT: NCT03398369 · UVAMRICRTTRIAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗