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NCT Number: NCT03398369

Mechanistic Clinical Trial of Advanced Imaging for CRT

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.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location status: Recruiting

Location contact

John Hoover

CONTACT

[email protected]

434-243-4861

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CMR/CTA Guidance for CRT

Diagnostic Test

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 outcomes

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

    Time frame: One Year

    Change in LVESV with cardiac resynchronization therapy (CRT)

Study contacts

Contact information is provided by the study sponsor or research team.

Hollis Phillips, BA

CONTACT

[email protected]

434-243-0046

Kenneth C Bilchick, MD

CONTACT

[email protected]

4349242465

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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