To assess the impact of a new feature in the treatment of patients not responding to standard Cardiac Resynchronization Therapy

Phase 4

• Conditions: Health Condition 1: null- Heart FailureHealth Condition 2: I501- Left ventricular failure, unspecified

• Registration Number: CTRI/2014/04/004556
• Lead Sponsor: St Jude Medical India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 6898

Inclusion Criteria

Eligible patients will meet ALL the following:

• Meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)

• Must be 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

Exclusion Criteria

Patients will be excluded if they meet ANY of the following criteria:

•Already had a CRT device implanted

•Myocardial Infarction, unstable angina within 40 days prior the enrollment

•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 requiring surgical correction

•Atrial Fibrillation:

ï?¼Persistent AF at the time of enrollment

ï?¼Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant

ï?¼History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment

•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

•Currently participating in any other clinical investigation

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of non-responder patients converted to responders after 6 months <br/ ><br>of MPP feature turned ON compared to baseline, as measured by Left <br/ ><br>Ventricular End Systolic Volume (LVESV) reduction of at least 15%Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
â?¢ Packerâ??s Clinical Composite Score evaluation between the baseline and the 12 month visit; and between the 6 month and the 12 month visit <br/ ><br>â?¢ Reverse LV remodelling, measured as changes in LVESV, LVEDD and LVEF <br/ ><br>â?¢ NYHA Class changes <br/ ><br>â?¢ 6 minutes walking test changes <br/ ><br>â?¢ Quality of Life (MLWHF and EQ-5D) changesTimepoint: 12 Months;Reduction of LVESV between baseline and 6 month visitTimepoint: 6 Months