Pressure Gradient vs. Flow Relationships in Patients With... | NCT05580237

Studies
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis

NCT05580237

Sponsor

Aarhus University Hospital Skejby

Status

Completed

Last Update Posted

Jan 3, 2024Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Simultaneous right and left heart catheterization

Countries

Denmark

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

May 10, 2022

First Submission Date that Met QC Criteria

Oct 12, 2022

First Posted Date

Oct 14, 2022Actual

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

Jan 2, 2024

Last Update Posted Date

Jan 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henrik Vase, Staff Specialist, MD, PhD, Aarhus University Hospital SkejbyPrincipal Investigator

Lead Sponsor

Aarhus University Hospital SkejbyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.

Detailed Description

Not provided

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe aortic valve stenosis			Procedure: Simultaneous right and left heart catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simultaneous right and left heart catheterization	Procedure	Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pressure and flow relationships across the aortic valve during rest and during supine exercise	Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
LVEF > 50 %
AVA < 1.0 cm2
Symptomatic - at least equivalent to NYHA functional class II

Exclusion Criteria:

Congenital heart disease
Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
Moderate or severe aortic valve regurgitation
Moderate or severe mitral valve regurgitation or stenosis
Moderate or severe pulmonary valve regurgitation or stenosis
Moderate or severe tricuspid valve regurgitation or stenosis
Severe pulmonary hypertension (tricuspid valve pressure gradient of 60 mmHg)
Right ventricular dysfunction (TAPSE < 17 mm)
Restrictive cardiomyopathy or cardiac amyloidosis
Constrictive pericarditis
Inability to perform supine bicycle exercise

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected severe AS scheduled for evaluation for aortic valve intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Vase, MD, PhD	Department of Cardiology, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided