Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

NCT ID: NCT03504891

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-01

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.

Detailed Description

The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.

Conditions

Chronic Systolic Heart Failure; Paroxysmal VT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRI Prior to CRT for Upgrades

MRI will be performed prior to CRT upgrade.

Group Type: EXPERIMENTAL

MRI prior to CRT Upgrade

Intervention Type: 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 de novo CRT Implants

MRI will be performed prior to de novo CRT implants.

Group Type: ACTIVE_COMPARATOR

MRI prior to de novo CRT

Intervention Type: DIAGNOSTIC_TEST

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

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.

Intervention Type: DIAGNOSTIC_TEST

MRI prior to de novo CRT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Bilchick, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth C Bilchick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kenneth C Bilchick, MD

Role: CONTACT

bilchick@virginia.edu

434-924-2465

Facility Contacts

Kenneth C Bilchick, MD

Role: primary

bilchick@virginia.edu

434-924-2465

Other Identifiers

MRI FOR CRT UPGRADES

Identifier Type: -

Identifier Source: org_study_id