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

Heart Failure Clinical Trial

Official title:

MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02402816
• Other study ID #: 1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: March 25, 2015
• Last updated: February 18, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: February 2016
• Source: Humanitas Hospital, Italy
• Contact: Maurizio Gasparini, MD
• Email: maurizio.gasparini[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months		up to 12 Months	No
Secondary	Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months		24-Months	No
Secondary	Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up		12-Months	No
Secondary	Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up		24-Months	No
Secondary	Percentage of responder patients in term of BNP < 400 pg/ml at 12 months		12 Months	No