Recruiting

Phase 1

Cardiac MRICardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

Sponsor:

University of Virginia

Code:

NCT03504891

Conditions

Chronic Systolic Heart Failure

Paroxysmal VT

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI prior to CRT Upgrade

MRI prior to de novo CRT

Study Details

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

Study ID

NCT03504891

Start date

Jan 1, 2018

Status verified date

Apr, 2018

Completion date

Jan 1, 2020

Anticipated

Primary completion date

Jan 1, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MRI Prior to CRT for Upgrades

MRI will be performed prior to CRT upgrade.

active comparator: MRI Prior to de novo CRT Implants

MRI will be performed prior to de novo CRT implants.

Interventions

MRI prior to CRT Upgrade

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 de novo CRT

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

Primary outcome measure

CRT Response [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kenneth C Bilchick, MD

434-924-2465 bilchick@virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22901

Contacts

Kenneth C Bilchick, MD

434-924-2465 bilchick@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 3, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-05-03.