Clinical trial NCT03091959: Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events .
Official title: Profiling of Implantable Cardiac Device Diagnostics Trends During Clinical Events for Co-morbid Conditions in Indian Patients- PATTERNS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.)

Detailed description: This is a multi-center, non-randomized, Non-interventional, data collection study with no subject follow-up visits required. Subjects will be enrolled and exited from the study during the same study visit.

The final analysis on the study will occur when 50 clinical events are reported on the study.All Medtronic implantable Cardiac Rhythm and Heart Failure devices with the Cardiac Compass® and OptiVol® feature which are commercially available at the start of the registry or become commercially available during the course of the registry and used within its intended use, may be included in the study.

After obtaining the informed consent patients will be interviewed to complete the "patient interview questionnaire". The study team will review medical records and complete the "Medical Record Review" form as completely as possible. The device will then be interrogated to download the cardiac Compass® report in a "save-to-disk" file and print the cardiac Compass® report for the PI or the designated clinician from the study team for review. The "device interrogation questionnaire" will then be discussed with the patient for specific events identified on the Cardiac Compass® report in order to determine possible explanations and fill out the questionnaire as completely as possible. After collection of all the study related data the patient will be exited on the same visit, so a followup visit is not required in the study.

Eligibility criteria: Inclusion Criteria:

1. Subject must be greater than 18 years of age.
2. Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
3. 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
4. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
5. 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.

Exclusion Criteria:

* Subject is unwilling or unable to give informed consent

Primary outcomes:
measure: Change in device measured diagnostic parameters
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Gurgaon
country: India
facility: Medanta - The Medicity
state: Haryana
city: Cochin
country: India
facility: LISIE Hospital
state: Kerala
city: Delhi
country: India
facility: Fortis Escort Hospital
Study officials:
affiliation: Medtronic
name: Vinay Rajan, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res. 2013 Feb;137(2):251-69.
citation: 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.