Cardiovascular DiseasesPATTERNSNCT03091959
Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events .
An observational study of Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 200 participants
- Where
- 4 sitesIndia
- Study dates
- 2 Mar 2017to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- Subject is unwilling or unable to give informed consent
Trial locations and contacts
4 sites in 1 country.
India4 sites
Fortis Escort Hospital
Delhi, 110025
Medanta - The Medicity
Gurgaon, Haryana, 122001
LISIE Hospital
Kochi, Kerala
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Profiling of Implantable Cardiac Device Diagnostics Trends During Clinical Events for Co-morbid Conditions in Indian Patients- PATTERNS Study
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.)
Read the 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.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start2 Mar 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinay Rajan, Phd, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091959
- Sponsor's protocol ID
- MDT16044
- Acronym
- PATTERNS
- Status last verified
- Aug 2018
- First submitted
- 24 Feb 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient identifiers will be anonymized and only the final results will be shared if there is a need.
Publications
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.
PubMed 27142605Sarnak 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.
PubMed 14581387Tharkar 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.
PubMed 19118912Varma 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.
PubMed 26060360Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res. 2013 Feb;137(2):251-69.
PubMed 23563369Chhabra 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.
PubMed 21302600
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling of Implantable Cardiac Device Diagnostics Trends During Clinical Events for Co-morbid Conditions in Indian Patients- PATTERNS Study
- ClinicalTrials.gov ID
- NCT03091959
- Acronym / sponsor ID
- PATTERNS / MDT16044
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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 :
- 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.
Key exclusion criteria (1 listed)
- Subject is unwilling or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in device measured diagnostic parameters
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 27142605Prabhakaran 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.
- Background: PubMed 14581387Sarnak 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.
- Background: PubMed 19118912Tharkar 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.
- Background: PubMed 26060360Varma 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.
- Background: PubMed 23563369Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res. 2013 Feb;137(2):251-69.
- Background: PubMed 21302600Chhabra 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.
- Individual participant dataSharing planned: No. All patient identifiers will be anonymized and only the final results will be shared if there is a need.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay Rajan, Phd study chair
Medtronic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in device measured diagnostic parameters (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091959, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.