Mechanistic Clinical Trial of Advanced Imaging for CRT
Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
1 other identifier
interventional
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2018
CompletedFirst Submitted
Initial submission to the registry
January 7, 2018
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedFebruary 6, 2020
February 1, 2020
7 years
January 7, 2018
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular end-systolic volume (LVESV) improvement
Change in LVESV with cardiac resynchronization therapy (CRT)
One Year
Study Arms (2)
Intervention
EXPERIMENTALCMR-Guided CRT
Control
NO INTERVENTIONStandard CRT
Interventions
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.
Eligibility Criteria
You may qualify if:
- Chronic systolic HF
- LVEF 35% or less
- Guideline-based class I or II indication for CRT
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth C Bilchick, MD
University of Virginia Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 7, 2018
First Posted
January 12, 2018
Study Start
January 5, 2018
Primary Completion
January 15, 2025
Study Completion
January 15, 2025
Last Updated
February 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share