Aortic Stenosis Clinical Trial
— BAVOfficial title:
Assessment of the Role of Balloon Aortic Valvuloplasty in the Management of Patients With Aortic Stenosis
Verified date | June 2017 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to determine the reasons for balloon aortic valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in patients with aortic stenosis. The ultimate aim is to establish the safety, effectiveness, and appropriate role of BAV therapy as definitive therapy (palliation) or as a "bridge" to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion criteria: Patients will be identified in the valve clinics and from the cath lab schedules. All patients who are scheduled to have a BAV during the study period in the cath lab at MCD and THHBP for whom a definitive pre-procedure BAV indication including the following will be eligible for enrollment: - BAV as palliation - BAV offered as a means of assessment for a change to operable status (a 'bridge' to decision). Patients in this category will be classified by the procedure physician as to the primary reason of 'bridge' decision - these reasons would include: - Diagnostic - Shortness of Breath- Aortic stenosis vs. other etiology such as COPD - Lack of Energy- Aortic stenosis vs. other etiology - LV Dysfunction - Aortic stenosis vs. cardiomyopathy - Therapeutic- determination of improvement to receive treatment - Frailty - Factors: grip strength, 5 meter walk time, Katz Index of Independence in Activities of Daily Living (Katz ADL), serum Albumin - Immobility - Reason for immobility and current assistive device will be documented - Stage IV chronic kidney disease - Cockoft- Gault formula (GRF 15-29 mL/min/1.73 m2) or high procedural risk for progression to dialysis dependence - End stage renal disease currently on dialysis Acute kidney Injury - (Varc 2) - Severe left ventricular dysfunction - BAV to improve EF (VARC 2) LVEF < 35% without contractile reserve - NYHA class IV congestive heart failure - Active bleeding - Urgent or emergent clinical status - Severe liver disease (VARC 2) - Active Infection - Other cause:_______________________________ The Kansas City Cardiomyopathy questionnaire (KCCQ), a quality of life (QOL) assessment, and the Connor-Davidson 10 Resilience Scale will be collected from all patients for whom informed consent is obtained by the study coordinators to administer the QOL assessment and resilience scale. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | Medical City | Dallas | Texas |
United States | The Heart Hospital Baylor | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BAV outcome as a successful "bridge to TAVR/AVR" procedure. | This is an observational study intended to collect re-world safety outcomes of BAV and delineate if patients that undergo this procedure to improve their clinical status actually improve to a point that they qualify for a definitive treatment for their aortic stenosis. | Up to 1 year post BAV. | |
Secondary | Measurement of improvement in primary cardiac function and symptomatology. | This is an observational study intended to collect re-world safety outcomes of BAV and delineate if patients that undergo this procedure to improve their clinical status actually improve to a point that they qualify for a definitive treatment for their aortic stenosis. Patients that undergo BAV will be followed up to 1 year post-BAV with NYHA class, quality of life scores and cardiac function (utilizing echocardiography) being tracked. | Up to 1 year post BAV. |
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