Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)

NCT ID: NCT01577446

Last Updated: 2016-10-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS \<120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Systolic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CRT

The CRT group undergoes implantation of a CRT defibrillator

Group Type EXPERIMENTAL

cardiac resynchronization therapy

Intervention Type PROCEDURE

Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads

no-CRT

The no-CRT group receives a dual-chamber defibrillator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiac resynchronization therapy

Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* NHYA class II-III heart failure
* ischemic cardiomyopathy
* ejection fraction of 35% or less
* QRS interval of 120ms or less
* evidence of mechanical dyssynchrony as measured on echocardiography

Exclusion Criteria

* conventional indication for cardiac pacing
* persistent atrial fibrillation
* life expectancy lower than 1 year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ospedale Santa Maria di Loreto Mare

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carmine Muto

Electrophysiology and Pacing Unit Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carmine Muto, MD

Role: STUDY_CHAIR

Ospedale Santa Maria di Loreto Mare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Santa Maria di Loreto Mare

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Muto C, Solimene F, Gallo P, Nastasi M, La Rosa C, Calvanese R, Iengo R, Canciello M, Sangiuolo R, Diemberger I, Ciardiello C, Tuccillo B. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):538-45. doi: 10.1161/CIRCEP.113.000135. Epub 2013 Apr 16.

Reference Type DERIVED
PMID: 23592833 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LM-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.