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Heart function and recovery after valve replacement for severe aortic stenosis

Looks at heart function and recovery in adults having a transcatheter aortic valve procedure.

Key facts

Who runs it
Guy's and St Thomas' NHS Foundation Trust
Where
London, United KingdomSee the site
Trial code
Registry title
Outcome Prediction in Patients With Aortic Stenosis After TAVI
Status
Not yet recruiting
People taking part
69 people, planned
Started
1 Oct 2023
Expected to end
1 Feb 2027
Type of study
Observational
Treatments tested
  • Transcatheter aortic valve implantation
Record updated
21 September 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis (a narrowed heart valve) causing symptoms, who are having TAVI through the groin artery. It studies heart function and recovery afterwards.

Age
18 Years and older
Sex
All
Disease stage
Severe aortic stenosis with symptoms: valve area <1.0 cm2 (<0.6cm2/m2), or mean gradient >40mmHg, or jet velocity >4.0 m/s.
Earlier treatment
People with a previous sternotomy (open-chest surgery through the breastbone) or a permanent pacemaker cannot join.

Main reasons for not taking part

  • TAVI done by a route other than the groin artery (non-transfemoral)
  • Heart pumping strength (LVEF) below 40%, unstable circulation or cardiogenic shock
  • Problems outside the heart that limit walking or exercise, or opting out of cardiac rehab
  • Severe COPD, primary pulmonary hypertension, poorly controlled AF, or signs of cardiac amyloid
  • More than moderate disease of another heart valve

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Patients with symptomatic severe aortic stenosis (AVA <1.0 cm2/<0.6cm2/m2 or mean gradient >40mmHg or jet velocity >4.0 m/s)

Who cannot take part

  • Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-transfemoral TAVI, haemodynamic instability/cardiogenic shock, LVEF <40%, poorly controlled AF, severe COPD, primary pulmonary hypertension, evidence of cardiac amyloid, more than moderate concomitant valvular heart disease other than aortic stenosis, previous sternotomy, permanent pacemaker implant, patients enrolled in another study where participation would involve deviation from either protocol

Where in United Kingdom

  • Guy's & St Thomas' NHS Foundation Trust, St Thomas' HospitalLondon, United KingdomContact: Ariella AmarNot yet recruiting

About the trial

What the trial wants to find out

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation

The group in the trial

  • Severe aortic stenosis

    Aortic valve area \<1.0 cm2/\<0.6cm2/m2 or mean gradient \>40mmHg or jet velocity \>4.0 m/s.

    Treatment: Transcatheter aortic valve implantation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).
Plain-language title
Heart function and recovery after valve replacement for severe aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
21 September 2023