Medtronic South Asian Systolic Heart Failure Registry (SASHFR)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01434615
First received: September 13, 2011
Last updated: November 8, 2012
Last verified: November 2012

September 13, 2011
November 8, 2012
October 2008
December 2013   (final data collection date for primary outcome measure)
Clinical Composite score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
1. To characterize the long term outcomes (clinical composite score as improved, unchanged or worsened) of patients who meet CRT implant guidelines and (a) receive CRT implant or (b) do not receive the CRT implant.
Same as current
Complete list of historical versions of study NCT01434615 on ClinicalTrials.gov Archive Site
  • Demographics [ Time Frame: 2 years FU ] [ Designated as safety issue: No ]
    To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.
  • Profile of patients with positive response to CRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF
CRT response [ Time Frame: 2 years FU ] [ Designated as safety issue: No ]
To characterize the profile of patients with a positive response to CRT.
Not Provided
Not Provided
 
Medtronic South Asian Systolic Heart Failure Registry
SASHFR (South Asian Systolic Heart Failure Registry) : A Multi-center, Nonrandomized, Prospective Study to Collect Data Pertaining to the Demographic and Cardiovascular Profiles, Management Strategies and Clinical Outcomes of HF Patients.

The purpose of this study is to (a) characterize the current management of patients with systolic heart failure (HF) in South Asia following an educational intervention of current guidelines and delivery of disease management tools and (b) to characterize the effect of current therapy on clinical outcomes in patients managed by tertiary care centers across South Asia. Current therapy includes characterization of the post market performance of any market released Medtronic cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac resynchronization therapy (CRT).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Heart Failure
  • Device: CRT
    Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device
  • Other: No-CRT
    Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted
  • Experimental: No-CRT
    Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted
    Intervention: Other: No-CRT
  • Experimental: CRT
    Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device
    Intervention: Device: CRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
502
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF < 35% as measured by echo, MUGA, contrast ventriculogram or MRI. QRS duration > 120 ms.

Exclusion Criteria:

Patient has life expectancy of less than 12 months due to medical conditions other than HF.

  • Patient has experienced unstable angina, acute myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months.
  • Patient is known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted).
  • Patient is enrolled in any concurrent study that would confound the results of this study.
  • Patient is pregnant or breastfeeding.
  • Patient has a CRT device implanted previously.
  • Patient has had a heart transplant.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01434615
SASHFR, CTRI/2008/091/000203
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Medtronic
Principal Investigator: C Narasimhan Care Hospital, Hyderabd-India
Medtronic Cardiac Rhythm Disease Management
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP