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

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: MultiPoint Pacing ON; Device: Implantable cardioverter-defibrillator (ICD)

• Registration Number: NCT02402816
• Lead Sponsor: Humanitas Hospital, Italy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19
• Study Start: 2016-05
• Primary Completion: 2017-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPP ON	MultiPoint Pacing ON	Patients will be randomized to the MPP-ON Arm vs Standard ICD
Standard ICD	Implantable cardioverter-defibrillator (ICD)	Patients will be randomized to the MPP-ON Arm vs Standard ICD

Primary Outcome Measures

Name	Time	Method
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months	up to 12 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months	24-Months
Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up	12-Months
Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up	24-Months
Percentage of responder patients in term of BNP < 400 pg/ml at 12 months	12 Months

Trial Locations

Locations (6)

A.O. Niguarda Ca' Granda; 🇮🇹 Milan, Italy

Ospedale Maggiore di Crema; 🇮🇹 Crema, Italy

Humanitas Research Hospital; 🇮🇹 Rozzano, Italy

Ospedale S.Maria della Misericordia; 🇮🇹 Rovigo, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Udine, Italy