Cardiac Resynchronization TherapyIMAGE-CRTNCT02713308
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
An observational study of Cardiac Resynchronization Therapy, run by Monaldi Hospital at 2 sites in Italy.
Trial summary
Observational, retrospective and perspective study with acute and chronic endpoints Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Resynchronization Therapy
- How many people
- 248 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2017to Apr 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with standard indication to CRT-D system implantation
Who may be able to join
- Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines
Who cannot join
- Right Bundle Branch Block
- Severe Irreversible Renal Failure (eGFR<30)
- NYHA IV
- Atrio-Ventricular Block above the 1st grade
- Prosthetic Valves
- Atrial Fibrillation at implantation
Trial locations and contacts
2 sites in 1 country.
Antonio D'Onofrio, MD contact
Italy2 sites, 2 recruiting
- Recruiting
Monaldi Hospital
Naples, 80100
Valter Bianchi, MD, valter.bianchi59@gmail.com
- Recruiting
Università della Campania "Luigi Vanvitelli"
Naples, 80100
Gerardo Nigro, Prof, gerardo.nigro@unina2.it
Vincenzo Russo, PhD, v.p.russo@libero.it
About this study
Observational, retrospective and perspective study with acute and chronic endpoints
Read the detailed description
Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation
- Conditions
- Cardiac Resynchronization Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1-CRT | Patients with RV-to-LV delay≥80ms, CRT standard programming (single-point) | |
| Group2-MPP | Patients with RV-to-LV delay<80ms, CRT programming with MPP (multi-point) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CRT responder patients
A patient is considered "responder" if Left Ventricular End-Systolic Volume at 6 Months from CRT-D system implantation is reduced at least of 15% towards the baseline value
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2020 (estimated)
- Study completionApr 2021 (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 Cardiac Resynchronization TherapyStudies 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
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monaldi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio D'Onofrio, Monaldi Hospital
- Investigators
- Antonio D'Onofrio, MD, Study chair, Monaldi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713308
- Sponsor's protocol ID
- MP001
- Acronym
- IMAGE-CRT
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
Publications
Solimene F, Nigro G, Canciello M, Tavoletta V, Shopova G, Calvanese R, Rago A, La Rosa C, Nappi F, Viscusi M, Urraro F, Manzo G, Gallo P, Andriani A, Rovaris G, Palmisano P, Innocenti S, D'Onofrio A. Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study. J Cardiovasc Med (Hagerstown). 2020 Mar;21(3):250-258. doi: 10.2459/JCM.0000000000000928.
PubMed 32004245
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
- ClinicalTrials.gov ID
- NCT02713308
- Acronym / sponsor ID
- IMAGE-CRT / MP001
- Conditions
- Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Monaldi HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 18 Mar 2016 (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.
Observational, retrospective and perspective study with acute and chronic endpoints
Detailed description
Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1-CRT | – | –Patients with RV-to-LV delay≥80ms, CRT standard programming (single-point) |
| Group2-MPP | – | –Patients with RV-to-LV delay<80ms, CRT programming with MPP (multi-point) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard indication to CRT-D system implantation
Key inclusion criteria (1 listed)
- Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines
Key exclusion criteria (6 listed)
- Right Bundle Branch Block
- Severe Irreversible Renal Failure (eGFR<30)
- NYHA IV
- Atrio-Ventricular Block above the 1st grade
- Prosthetic Valves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of CRT responder patients
Time frame: 6 Months
A patient is considered "responder" if Left Ventricular End-Systolic Volume at 6 Months from CRT-D system implantation is reduced at least of 15% towards the baseline value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 32004245Solimene F, Nigro G, Canciello M, Tavoletta V, Shopova G, Calvanese R, Rago A, La Rosa C, Nappi F, Viscusi M, Urraro F, Manzo G, Gallo P, Andriani A, Rovaris G, Palmisano P, Innocenti S, D'Onofrio A. Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study. J Cardiovasc Med (Hagerstown). 2020 Mar;21(3):250-258. doi: 10.2459/JCM.0000000000000928.
Related trials for Cardiac Resynchronization Therapy
Recruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Active, not recruiting
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
Heart Failure
Recruiting
Bachmann's Bundle Versus Right Atrial Appendage Pacing
Atrial Fibrillation (AF)
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.
Antonio D'Onofrio, MD contact
Antonio D'Onofrio, MD study chair
Monaldi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization Therapy, run by Monaldi Hospital at 2 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 6 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Antonio D'Onofrio, MD (donofrioant1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CRT responder patients (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 NCT02713308, 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 12 Mar 2020.