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Trial record 53 of 132 for:    "Paroxysmal Ventricular Fibrillation"

Italian Registry On Multipoint Left Ventricular Pacing (IRON-MPP)

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ClinicalTrials.gov Identifier: NCT02606071
Recruitment Status : Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Giovanni B Forleo, Luigi Sacco University Hospital

Brief Summary:

The IRON-MPP is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of HF patients treated in clinical practice with a CRT-D device with the ability to deliver Multi Point Pacing.

The purpose of the Registry is to collect data on how MPP-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of MPP therapy.


Condition or disease Intervention/treatment
Heart Failure Ventricular Fibrillation Ventricular Tachycardia Device: CRT-D

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Study Type : Observational [Patient Registry]
Actual Enrollment : 436 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Italian Registry On Multipoint Left Ventricular
Study Start Date : August 2013
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : September 2018



Intervention Details:
  • Device: CRT-D
    HF patients treated in clinical practice with a CRT-D device


Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 6 Months ]
    Changes in Left ventricular ejection fraction


Secondary Outcome Measures :
  1. Heart Failure Hospitalizations [ Time Frame: 12 months ]
  2. Appropriate device interventions [ Time Frame: 12 months ]
    Number of participants with appropriate device interventions (anti-tachycardia pacing or shock)

  3. Echocardiographic changes [ Time Frame: 12 months ]
    Left ventricular end systolic volume

  4. QRS Duration [ Time Frame: Baseline and six months ]
    Changes in QSR duration between MPP and conventional biventricular pacing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HF patients treated in clinical practice with a CRT-D device with the ability to deliver MPP
Criteria

Inclusion Criteria:

- Patients implanted with a St. Jude Medical CRT-D system with MPP capability

Exclusion Criteria:

- Patients currently participating in any other clinical investigation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606071


Locations
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Italy
Ospedale Santa Maria della Misericordia
Rovigo, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Ospedale Maria Vittoria
Torino, Italy
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: Giovanni Forleo Policlinico Tor Vergata

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni B Forleo, MD, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT02606071     History of Changes
Other Study ID Numbers: MPP04
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Giovanni B Forleo, Luigi Sacco University Hospital:
cardiac resynchronization therapy
multipoint left ventricular pacing

Additional relevant MeSH terms:
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Heart Failure
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes