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Medtronic South Asian Systolic Heart Failure Registry (SASHFR)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
CRT
No-CRT
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Moderate to advanced, patients, current consensus guidelines

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

No-CRT

CRT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical Composite score
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
To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.
Profile of patients with positive response to CRT
To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF

Full Information

First Posted
September 13, 2011
Last Updated
December 5, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01434615
Brief Title
Medtronic South Asian Systolic Heart Failure Registry
Acronym
SASHFR
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization Therapy, Moderate to advanced, patients, current consensus guidelines

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No-CRT
Arm Type
Experimental
Arm Description
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
Arm Title
CRT
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
CRT
Intervention Description
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 Type
Other
Intervention Name(s)
No-CRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Composite score
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Demographics
Description
To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.
Time Frame
2 years FU
Title
Profile of patients with positive response to CRT
Description
To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Narasimhan
Organizational Affiliation
Care Hospital, Hyderabd-India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 034
Country
India

12. IPD Sharing Statement

Learn more about this trial

Medtronic South Asian Systolic Heart Failure Registry

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