Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

NCT03504891 | Unknown Phase 1 DMC FDA Device

• 1 other identifier: MRI FOR CRT UPGRADES
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.

Conditions

Chronic Systolic Heart Failure; Paroxysmal VT

Outcome Measures

Primary Outcomes (1)

• CRT Response

  CRT Response Based on Change in LVESV After CRT

  6 months

Secondary Outcomes (2)

• Improvement in Peak Oxygen Consumption

  6 months

• Improvement in Short Form (36) Health Survey

  6 months

Study Arms (2)

MRI Prior to CRT for Upgrades

EXPERIMENTAL

MRI will be performed prior to CRT upgrade.

Diagnostic Test: MRI prior to CRT Upgrade

MRI Prior to de novo CRT Implants

ACTIVE COMPARATOR

MRI will be performed prior to de novo CRT implants.

Diagnostic Test: MRI prior to de novo CRT

Interventions

MRI prior to CRT Upgrade DIAGNOSTIC_TEST

We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups.

MRI Prior to CRT for Upgrades

MRI prior to de novo CRT DIAGNOSTIC_TEST

We will perform MRI prior to de novo CRT implants as the comparison group.

MRI Prior to de novo CRT Implants

Eligibility Criteria

• Age: 25 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Undergoing upgrade from an existing pacemaker or ICD to a CRT device.

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 MRI (pacemakers and ICDs are allowed)
• severe claustrophobia
• acute kidney injury
• acute renal failure
• gadolinium allergy
• abandoned leads

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22901, United States

RECRUITING

Study Officials

• Kenneth C Bilchick, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth C Bilchick, MD

CONTACT

434-924-2465; bilchick@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Patients will have cardiac MRI prior to CRT.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years
• Access Criteria: Not yet available.

Locations

US (1)