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
  Purpose

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).


Condition Intervention Phase
Heart Failure
Device: CRT
Other: No-CRT
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 502
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 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
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434615

Locations
India
Care Hospital
Hyderabad, Andhra Pradesh, India, 500 034
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Principal Investigator: C Narasimhan Care Hospital, Hyderabd-India
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01434615     History of Changes
Other Study ID Numbers: SASHFR, CTRI/2008/091/000203
Study First Received: September 13, 2011
Last Updated: November 8, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Cardiac Resynchronization Therapy
Moderate to advanced
patients
current consensus guidelines

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014