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Mechanistic Clinical Trial of Advanced Imaging for CRT

Primary Purpose

Heart Failure, Systolic

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CMR/CTA Guidance for CRT

About this trial

This is an interventional treatment trial for Heart Failure, Systolic

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic systolic HF
LVEF 35% or less
Guideline-based class I or II indication for CRT

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 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.

Sites / Locations

University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

CMR-Guided CRT

Standard CRT

Outcomes

Primary Outcome Measures

Left ventricular end-systolic volume (LVESV) improvement

Change in LVESV with cardiac resynchronization therapy (CRT)

Secondary Outcome Measures

Full Information

NCT ID

NCT03398369

First Posted

January 7, 2018

Last Updated

February 4, 2020

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT03398369

Brief Title

Mechanistic Clinical Trial of Advanced Imaging for CRT

Official Title

Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Recruiting

Study Start Date

January 5, 2018 (Actual)

Primary Completion Date

January 15, 2025 (Anticipated)

Study Completion Date

January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Systolic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

CMR-Guided CRT

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard CRT

Intervention Type

Diagnostic Test

Intervention Name(s)

CMR/CTA Guidance for CRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Left ventricular end-systolic volume (LVESV) improvement

Description

Change in LVESV with cardiac resynchronization therapy (CRT)

Time Frame

One Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic systolic HF LVEF 35% or less Guideline-based class I or II indication for CRT 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kenneth C Bilchick, MD

Phone

4349242465

bilchick@virginia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Hollis Phillips, BA

Phone

434-243-0046

hp9r@hscmail.mcc.virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth C Bilchick, MD

Organizational Affiliation

University of Virginia Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Health System

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Hoover

Phone

434-243-4861

jrh5r@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Plan to Share IPD

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Mechanistic Clinical Trial of Advanced Imaging for CRT

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