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

H

Humanitas Hospital, Italy

Status

Unknown

Conditions

Heart Failure

Treatments

Device: Implantable cardioverter-defibrillator (ICD)
Device: MultiPoint Pacing ON

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

MPP ON
Experimental group
Description:
Patients will be randomized to the MPP-ON Arm vs Standard ICD
Treatment:
Device: MultiPoint Pacing ON
Standard ICD
Active Comparator group
Description:
Patients will be randomized to the MPP-ON Arm vs Standard ICD
Treatment:
Device: Implantable cardioverter-defibrillator (ICD)

Trial contacts and locations

6

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Central trial contact

Maurizio Gasparini, MD

Data sourced from clinicaltrials.gov

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