Prospective Balloon Aortic Valvuloplasty

NCT02122900 | Completed DMC

• 1 other identifier: 013-142
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of improvement in primary cardiac function and symptomatology.

  Up to 1 year post BAV.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Aortic Stenosis

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

You may not qualify if:

• None

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (2)

Medical City

Dallas, Texas, 75230, United States

Location

The Heart Hospital Baylor

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Molly Szerlip, MD

  Baylor Research Instute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: April 25, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

US (2)