MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec

NCT ID: NCT02402816

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-05-31

Brief Summary

The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

MPP ON

Patients will be randomized to the MPP-ON Arm vs Standard ICD

Group Type: EXPERIMENTAL

MultiPoint Pacing ON

Intervention Type: DEVICE

MultiPoint Pacing ON

Standard ICD

Patients will be randomized to the MPP-ON Arm vs Standard ICD

Group Type: ACTIVE_COMPARATOR

Implantable cardioverter-defibrillator (ICD)

Intervention Type: DEVICE

Implantable cardioverter-defibrillator (ICD)

Interventions

MultiPoint Pacing ON

MultiPoint Pacing ON

Intervention Type: DEVICE

Implantable cardioverter-defibrillator (ICD)

Implantable cardioverter-defibrillator (ICD)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with EF < 35% on OPT at least 3 months and candidate to ICD
• QRS duration: 100-130 ms
• Patients willing and able to comply with study requirements
• Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
• Successful quadripolar LV lead implant (only for Treatment Group)

Exclusion Criteria

• Myocardial Infarction, unstable angina within 40 days prior the enrollment
• Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test
• Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
• Primary valvular disease
• Unable to comply with the follow up schedule
• Less than 18 years of age
• Pregnant or are planning to become pregnant during the duration of the investigation
• Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
• Undergone a cardiac transplantation
• Life expectancy < 12 months
• Patients with permanent Atrial fibrillation
• Patients with Nyha 1

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: lead

Responsible Party

Dr.Maurizio Gasparini

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio Gasparini, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital-Rozzano-Italy

Locations

Ospedale Maggiore di Crema

Crema, , Italy

A.O. Niguarda Ca' Granda

Milan, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Ospedale S.Maria della Misericordia

Rovigo, , Italy

Humanitas Research Hospital

Rozzano, , Italy

Ospedale Santa Maria della Misericordia

Udine, , Italy

Countries

Italy

Central Contacts

Maurizio Gasparini, MD

Role: CONTACT

maurizio.gasparini@humanitas.it

Facility Contacts

Maurizio Landolina, MD

Role: primary

Maurizio Lunati, MD

Role: primary

Roberto Rordorf, MD

Role: primary

Francesco Zanon, MD

Role: primary

Maurizio Gasparini, MD

Role: primary

Alessandro Proclemer, MD

Role: primary

References

Gasparini M, Galimberti P, Bragato R, Ghio S, Raineri C, Landolina M, Chieffo E, Lunati M, Mulargia E, Proclemer A, Facchin D, Rordorf R, Vicentini A, Marcantoni L, Zanon F, Klersy C. Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial. Trials. 2016 Dec 3;17(1):572. doi: 10.1186/s13063-016-1698-1.

Reference Type: DERIVED

PMID: 27927248 (View on PubMed)

Other Identifiers

1.0

Identifier Type: -

Identifier Source: org_study_id