MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)

NCT ID: NCT02728336

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2026-08-31

Brief Summary

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The goals of this project are to: 1) explore the potential use of magnetic resonance imaging (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use the MRI-derived data together with a computer model of the cardiovascular system to study the relative roles of different factors in the mechanical effects of dyssynchrony in failure, and in the response (or lack thereof) to CRT.

Detailed Description

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Conditions

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Cardiac Resynchronization Therapy Magnetic Resonance Imaging (MRI)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Heart Failure Patients

patients who are scheduled to undergo clinically ordered CRT for heart failure complicated by dyssynchrony

Group Type ACTIVE_COMPARATOR

Cardiac MRI

Intervention Type PROCEDURE

Control

20 matched control subjects

Group Type ACTIVE_COMPARATOR

Cardiac MRI

Intervention Type PROCEDURE

Interventions

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Cardiac MRI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients ages 18 and over scheduled by conventional criteria (symptomatic impairment of cardiac function with broadened QRS) for clinical CRT procedures at NYULMC.
* Normal kidney function as determined by GFR levels.


* Normal kidney function as determined by GFR levels
* No significant cardiovascular disease or risk factors.

Exclusion Criteria

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing (which will be removed)
* pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leon Axel, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-01686

Identifier Type: -

Identifier Source: org_study_id

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