NCT06129799

Brief Summary

Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

November 6, 2023

Last Update Submit

November 9, 2023

Conditions

Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (1)

  • Composite of events: number of participants with cardiovascular death or heart failure hospitalisation

    12 months

Study Arms (2)

paradoxical LF-LG AS

conventional LF-LG AS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients prior to TAVR

You may qualify if:

  • paradoxical or conventional severe low-flow low-gradient aortic stenosis

You may not qualify if:

  • CMR incapable device
  • unable to undergo 40 min scan (can not lie flat, claustrophobia)
  • renal insufficiency (eGFR \<30 ml/min/1.73m²)
  • allergy against contrast agent
  • unable to exercise in supine position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Goettingen

Göttingen, 37073, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

DE(1)