Recruiting

Cardiac MRI

Sponsor:

Kenneth Bilchick, MD

Code:

NCT03183011

Conditions

Heart Failure, Systolic

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

Brief summary:

This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

Conditions

Heart Failure, Systolic

Study ID

NCT03183011

Start date

Nov 1, 2016

Status verified date

Jun, 2017

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Oct 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Chronic systolic HF
  • LVEF 35% or less
  • Guideline-based class I or IIa indication for CRT
  • 25 and 85 years old
  • Predominantly in sinus rhythm
  • GFR ≥ 40 ml/min/1.73m2\* \*Contrast will not be given for the 6-month follow-up scan if the GFR falls to < 40 ml/min/1.73m2.

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
  • Preexisting pacemaker or defibrillator prior to enrollment
  • Cerebral aneurysm clips; 6) cochlear implants
  • Other metallic implants (prior to enrollment) known to be contraindications to MRI
  • Severe claustrophobia
  • Acute kidney injury
  • Acute renal failure or chronic kidney disease with GFR < 40 cc/min
  • Liver transplant
  • Gadolinium allergy

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Post-CRT MRI

This study has a single arm. Enrolled patients will follow the protocol as described, including evaluation with MRI, echocardiography, and cardiopulmonary exercise testing.

Interventions

MRI

Cardiac MRI

Primary outcome measure

  • CRT Response [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kenneth C Bilchick, MD

434-924-2465bilchick@virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22901

Contacts

Kenneth C Bilchick, MD

434-924-2465bilchick@virginia.edu

More Information

Sponsor

Kenneth Bilchick, MD

Last update posted

Jun 12, 2017

Last verified

Jun, 2017

Keywords

  • cardiac resynchronization therapy
  • implantable cardioverter defibrillator
  • heart failure
  • magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kenneth Bilchick, MD on 2017-06-12.