CTRI/2014/04/004556
Recruiting
Phase 4
MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPointPacing (MPP) - More-CRT MPP
St Jude Medical India Pvt Ltd0 sites6,898 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- St Jude Medical India Pvt Ltd
- Enrollment
- 6898
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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