Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay

NCT ID: NCT02713308

Last Updated: 2020-03-12

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

UNKNOWN

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-04-30

Brief Summary

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Observational, retrospective and perspective study with acute and chronic endpoints

Detailed Description

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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

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Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1-CRT

Patients with RV-to-LV delay≥80ms, CRT standard programming (single-point)

No interventions assigned to this group

Group2-MPP

Patients with RV-to-LV delay\<80ms, CRT programming with MPP (multi-point)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monaldi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antonio D'Onofrio

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio D'Onofrio, MD

Role: STUDY_CHAIR

Monaldi Hospital

Locations

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Monaldi Hospital

Naples, , Italy

Site Status RECRUITING

Università della Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio D'Onofrio, MD

Role: CONTACT

Facility Contacts

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Valter Bianchi, MD

Role: primary

Gerardo Nigro, Prof

Role: primary

Vincenzo Russo, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 32004245 (View on PubMed)

Other Identifiers

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MP001

Identifier Type: -

Identifier Source: org_study_id

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