Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events .

NCT03091959 | Completed

• 1 other identifier: MDT16044
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The study looks to evaluate the device diagnostic data obtained from (all the Cardiac Rhythm and Heart Failure (CRHF) devices of medtronic having the Cardiac Compass® and OptiVol® diagnostic feature) these devices to identify trends during clinical events that will help early detection and prevention of cardiovascular and other comorbid conditions. (i.e. Heart failure(HF), Atrial Fibrilation,COPD, Renal dysfunction (RD), Diabetes etc.)

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in device measured diagnostic parameters

  Determine a combined diagnostic index that can identify patient at risk for a clinical event Determine the number of device measured diagnostic parameter that change prior to any clinical events associated with at least one of the comorbid conditions, including worsening heart failure, COPD, diabetes, and renal failure, which require major medication change, IV drug therapy, hospitalization, outside home treatment.

  The diagnostic parameters can be stored within device for upto 12 months and this will be evaluated once the patient is interrogated and the report analyzed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll up to 300 subjects (i.e. consented) from upto 7 sites. All subjects implanted with devices (Medtronic Cardiac Rythm and Heart Failure (CRHF) implantable devices with Cardiac compass and Optivol feature) will be considered eligible for the study.

You may qualify if:

• Subject must be greater than 18 years of age.
• Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
• Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions :
• Heart failure
• Chronic Obstructive Pulmonary Disease (COPD)
• Renal deficiency
• Atrial fibrillation
• Diabetes
• Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
• If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition.

You may not qualify if:

• Subject is unwilling or unable to give informed consent

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

Medanta - The Medicity

Gurgaon, Haryana, 122001, India

Location

LISIE Hospital

Kochi, Kerala, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Fortis Escort Hospital

Delhi, 110025, India

Location

Related Publications (6)

• Prabhakaran D, Jeemon P, Roy A. Cardiovascular Diseases in India: Current Epidemiology and Future Directions. Circulation. 2016 Apr 19;133(16):1605-20. doi: 10.1161/CIRCULATIONAHA.114.008729.

  PMID: 27142605 BACKGROUND

• Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation. 2003 Oct 28;108(17):2154-69. doi: 10.1161/01.CIR.0000095676.90936.80. No abstract available.

  PMID: 14581387 BACKGROUND

• Tharkar S, Satyavani K, Viswanathan V. Cost of medical care among type 2 diabetic patients with a co-morbid condition--hypertension in India. Diabetes Res Clin Pract. 2009 Feb;83(2):263-7. doi: 10.1016/j.diabres.2008.11.027. Epub 2008 Dec 31.

  PMID: 19118912 BACKGROUND

• Varma PP. Prevalence of chronic kidney disease in India - Where are we heading? Indian J Nephrol. 2015 May-Jun;25(3):133-5. No abstract available.

  PMID: 26060360 BACKGROUND

• Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res. 2013 Feb;137(2):251-69.

  PMID: 23563369 BACKGROUND

• Chhabra SK, Gupta M. Coexistent chronic obstructive pulmonary disease-heart failure: mechanisms, diagnostic and therapeutic dilemmas. Indian J Chest Dis Allied Sci. 2010 Oct-Dec;52(4):225-38.

  PMID: 21302600 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Vinay Rajan, Phd

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 27, 2017
• Study Start: March 2, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)