Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease

NCT02266251 | Completed

• 2 other identifiers: Pro00052757CER-1306-04350
• Study Type: observational
• Target: 273,365
• Locations: 1 country
• Sites: 1

Brief Summary

Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics. The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The corner-stone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality will be analyzed in a time-to event analysis. Mortality follow-up will be considered to be administratively censored on the last date of Medicare follow-up which is expected to be 12/31/2013 for both surgical and transcatheter AVR.

  one-year survival

Secondary Outcomes (3)

• Stroke

  during 1st year after surgical or transcatheter AVR

• Discharged to home following the procedure (TAVR or SAVR)

  STS ACSD (July 2011-June 2012) and STS/ACC TVT Registry (Nov 2011-March 2013)

• days alive and out of the hospital during the first post-operative year

  number of days (out of 365) that the patient is alive and out of hospital during the first year post-operatively

Study Arms (2)

Surgical AVR

No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the Transcatheter Valve Therapies (TVT) Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS Adult Cardiac Surgical DAtabase (ACSD) (Jan 2011-Dec 2013).

Transcatheter AVR

No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the TVT Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS ACSD (Jan 2011-Dec 2013).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To compare health outcomes among patients with a similar baseline health status who are eligible for surgical and transcather AVR procedures, we will include 1)'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013), and 2) surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013).

You may qualify if:

• 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013)
• surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)

You may not qualify if:

• We will exclude patients with endocarditis or emergency/salvage status because these patients are rarely treated using transcatheter AVR in the United States (\<0.2% incidence of either condition during the first year of TVT Registry data).

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• American College of Cardiology: collaborator
• The Society of Thoracic Surgeons: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• James M Brennan, MD, MPH

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 16, 2014
• Study Start: May 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)