Transcatheter Aortic Prosthesis Function: A Long-term Fol... | NCT03002272

Studies
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

NCT03002272

Sponsor

Medstar Health Research Institute

Status

Recruiting

Last Update Posted

May 26, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Aortic Valve Replacement

Interventions

TAVR
SAVR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2018Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Dec 21, 2016

First Submission Date that Met QC Criteria

Dec 21, 2016

First Posted Date

Dec 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2023

Last Update Posted Date

May 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

Detailed Description

There is limited available information on long term TAVR valve function. In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAVR		This observational study will enroll subjects that underwent TAVR more than 3 years ago.	Device: TAVR
SAVR		Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago	Device: SAVR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAVR	Device	subjects that underwent TAVR more than 3 years ago	TAVR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prosthetic valve dysfunction	Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation	7 years

Secondary Outcomes

Measure	Description	Time Frame
Change in functional status	Change in functional status from baseline and discharge per NYHA classification	discharge from hospital
Increase in severity of aortic regurgitation	Increase in severity of aortic regurgitation by one or more grading of severity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

Subjects unable to consent to participate, unless the subject has a legally authorized representative
Subjects unwilling to participate
Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Inclusion criteria for SAVR subjects

SAVR performed more than 3 years ago
Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This observational study will enroll subjects that underwent TAVR more than 3 years ago. TAVR.

Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Sampling Method

Non-Probability Sample