Mechanistic Clinical Trial of Advanced Imaging for CRT

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT03398369
Collaborator
(none)
180
1
2
84.3
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CMR/CTA Guidance for CRT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
Actual Study Start Date :
Jan 5, 2018
Anticipated Primary Completion Date :
Jan 15, 2025
Anticipated Study Completion Date :
Jan 15, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Left ventricular end-systolic volume (LVESV) improvement [One Year]

    Change in LVESV with cardiac resynchronization therapy (CRT)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
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:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Health System Charlottesville Virginia United States 22908

Sponsors and Collaborators

  • University of Virginia

Investigators

  • Principal Investigator: Kenneth C Bilchick, MD, University of Virginia Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenneth Bilchick, MD, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier:
NCT03398369
Other Study ID Numbers:
  • UVAMRICRTTRIAL
First Posted:
Jan 12, 2018
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2020