Medtronic South Asian Systolic Heart Failure Registry

NCT01434615 | Completed Phase 4

• 2 other identifiers: SASHFRCTRI/2008/091/000203
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy; Moderate to advanced; patients; current consensus guidelines

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Demographics

  2 years FU

• Profile of patients with positive response to CRT

  2 years

Study Arms (2)

No-CRT

EXPERIMENTAL

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

CRT

EXPERIMENTAL

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

Interventions

CRT DEVICE

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

CRT

No-CRT OTHER

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

No-CRT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

Care Hospital

Hyderabad, Andhra Pradesh, 500 034, India

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• C Narasimhan

  Care Hospital, Hyderabd-India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: October 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

IN (1)