Mechanistic Clinical Trial of Advanced Imaging for CRT

February 4, 2020 updated by: Kenneth Bilchick, MD, University of Virginia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
CMR-Guided CRT
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.
NO_INTERVENTION: Control
Standard CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular end-systolic volume (LVESV) improvement
Time Frame: One Year
Change in LVESV with cardiac resynchronization therapy (CRT)
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2018

Primary Completion (ANTICIPATED)

January 15, 2025

Study Completion (ANTICIPATED)

January 15, 2025

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

January 7, 2018

First Posted (ACTUAL)

January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVAMRICRTTRIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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