Prospective Balloon Aortic Valvuloplasty

Completed

Conditions studied: Aortic Stenosis

In brief

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).

Key facts

Study ID

NCT02122900

Run by

Baylor Research Institute

People needed

100

Starts

2013-06-01

Expected to finish

2015-12-01

Last updated by the study team

2017-06-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None

Where it is running

• Medical City — Dallas, Texas, United States
• The Heart Hospital Baylor — Plano, Texas, United States

Full record on ClinicalTrials.gov

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