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Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning

NCT03145376 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-10-30

No results posted yet for this study

Summary

Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip .

The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular surgeon, an anesthesiologist and a geriatrician.

The Geriatrician is called to make a careful multidimensional assessment of the elderly patients who have been suggested for the interventions mentioned above. His role is to assess the degree of co-morbidity and polypathology, autonomy in the common activities of daily living, nutritional status, cognitive status and quality of life. Following this evaluation, together with the other components of Heart Team, it is expressed a collective judgment on the patient's eligibility to these interventions. So, the aim of the present study is to identify changes in the degree of cognitive decline, of autonomy in carrying out activities of daily living, quality of life, nutritional status, pre- and postoperatively (6 months after the procedure) polypathology degree in elderly patients to be undergone or undergoing TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete echocardiographic evaluation.

Conditions

  • Mitral Valve Insufficiency
  • Aortic Stenosis Senile

Interventions

DIAGNOSTIC_TEST

geriatric assessment

1. Clinical evaluation and geriatric assessment with: 1. CIRS: CIRS (Cumulative Illness Rating Scale) 2. ADL (Activities of Daily Living); 3. IADL (InstrumentalActivities of Daily Living); 4. Mini Nutritional Assessment; 5. Evaluation of quality of life (Short Form 36, SF-36). 2. Making a traditional 12-lead ECG. 3. A single lead electrocardiographic registration (DI, D II and D III) of 5 minutes baseline and 5 minutes with controlled breathing (15 breaths / min), using the Spectralink 2011 program, which allows us to identify and calculate the variables object of study; 4. transthoracic echocardiogram.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Gianfranco Piccirillo, MD, PhD · Sapienza

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2020-05-30
Completion
2020-10-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145376 on ClinicalTrials.gov