Heart FailureIRON-MPPNCT02606071
Italian Registry On Multipoint Left Ventricular Pacing
An observational study of Heart Failure and Ventricular Fibrillation, run by University of Rome Tor Vergata at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- CRT-D
- Type of treatment
- Medical device
- How many people
- 436 participants
- Where
- 3 sitesItaly
- Study dates
- Aug 2013to Sep 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HF patients treated in clinical practice with a CRT-D device with the ability to deliver MPP
Who may be able to join
- Patients implanted with a St. Jude Medical CRT-D system with MPP capability
Who cannot join
- Patients currently participating in any other clinical investigation
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Santa Maria della Misericordia
Rovigo
Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ospedale Maria Vittoria
Torino
About this study
Official title: Italian Registry On Multipoint Left Ventricular
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.
- Being tested
- CRT-D
- Keywords
- cardiac resynchronization therapy, multipoint left ventricular pacing
- Medical subject headings
- Heart Failure, Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
HF patients treated in clinical practice with a CRT-D device
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Changes in Left ventricular ejection fraction
Measured: 6 Months
Secondary outcomes (4)
Heart Failure Hospitalizations
Measured: 12 months
Appropriate device interventions
Number of participants with appropriate device interventions (anti-tachycardia pacing or shock)
Measured: 12 months
Echocardiographic changes
Left ventricular end systolic volume
Measured: 12 months
QRS Duration
Changes in QSR duration between MPP and conventional biventricular pacing
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 436 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni B Forleo, Luigi Sacco University Hospital
- Investigators
- Giovanni Forleo, Principal investigator, Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606071
- Sponsor's protocol ID
- MPP04
- Acronym
- IRON-MPP
- Status last verified
- Sep 2017
- First submitted
- 6 Nov 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Forleo GB, Santini L, Giammaria M, Potenza D, Curnis A, Calabrese V, Ricciardi D, D'agostino C, Notarstefano P, Ribatti V, Morani G, Mantica M, Di Biase L, Bertaglia E, Calo L, Zanon F. Multipoint pacing via a quadripolar left-ventricular lead: preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace. 2017 Jul 1;19(7):1170-1177. doi: 10.1093/europace/euw094.
PubMed 27189954
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry On Multipoint Left Ventricular
- ClinicalTrials.gov ID
- NCT02606071
- Acronym / sponsor ID
- IRON-MPP / MPP04
- Keywords
- cardiac resynchronization therapy, multipoint left ventricular pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 436 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HF patients treated in clinical practice with a CRT-D device with the ability to deliver MPP
Key inclusion criteria (1 listed)
- Patients implanted with a St. Jude Medical CRT-D system with MPP capability
Key exclusion criteria (1 listed)
- Patients currently participating in any other clinical investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-DHF patients treated in clinical practice with a CRT-D device | Device | – |
Primary outcome
Left ventricular ejection fraction
Time frame: 6 Months
Changes in Left ventricular ejection fraction
4 secondary outcomes
Heart Failure Hospitalizations
Time frame: 12 months
Appropriate device interventions
Time frame: 12 months
Echocardiographic changes
Time frame: 12 months
QRS Duration
Time frame: Baseline and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Derived from this study: PubMed 27189954Forleo GB, Santini L, Giammaria M, Potenza D, Curnis A, Calabrese V, Ricciardi D, D'agostino C, Notarstefano P, Ribatti V, Morani G, Mantica M, Di Biase L, Bertaglia E, Calo L, Zanon F. Multipoint pacing via a quadripolar left-ventricular lead: preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace. 2017 Jul 1;19(7):1170-1177. doi: 10.1093/europace/euw094.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Forleo principal investigator
Policlinico Tor Vergata
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ventricular Fibrillation, run by University of Rome Tor Vergata at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02606071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.