Heart Failure
Conditions
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.
Interventions
DEVICEMultiPoint Pacing ON
MultiPoint Pacing ON
Implantable cardioverter-defibrillator (ICD)
Sponsors
Humanitas Hospital, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months | up to 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactMaurizio Gasparini, MD
Outcome results
None listed