Aortic StenosisTAVI-NORNCT04417829
Transcatheter Aortic Valve Implantation in Western NORway
An observational study of Aortic Stenosis and Hypertension, run by Haukeland University Hospital.
Trial summary
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Hypertension
- What is being tested?
- Biological prosthesis in the aortic valve
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jul 2019
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 600 patients with moderate or severe aortic stenosis of any etiology, and symptoms, where aortic valve intervention was clinially indicated. All patients underwent a successful TAVI (transcatheter aortic valve implantation).
Who may be able to join
- Hemodynamically severe aortic stenosis and symptoms
- A decision of TAVI by Heart team
- Patients undergoing TAVI (transcatheter aortic valve implantation)
- Life expectancy > 1-2 years
Who cannot join
- Sever frailty
- Severly reduced cognitive function
- Multiple comorbid conditions
- Technically not suited for TAVI
About this study
Official title: The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.
Read the detailed description
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and July 2019.
Demographics, clinical data including cardiovascular risk factors, arterial and echocardiographic parameters were prospectively collected. The data on all-cause mortality will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at 6-12 months follow-up) will be analyzed. The main scientific objectives are:
To assess survival benefits of TAVI according to baseline risk profile. To determine the echocardiographic predictors of left ventricular mass regression and left ventricular function recovery.
To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the impact of various types of blood pressure responses immediately after TAVI on clinical outcomes.
- Conditions
- Aortic Stenosis, Hypertension
- Being tested
- Biological prosthesis in the aortic valve
- Keywords
- Aortic stenosis, Echocardiography, Transcutaneous aortic valve implantation, Left ventricular dysfunction, Left ventricular hypertrophy, Mortality
- Medical subject headings
- Aortic Valve Stenosis, Hypertension, Ventricular Dysfunction, Left, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological prosthesis in the aortic valveDevice
Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)
| Study group | Role | What they receive |
|---|---|---|
| Only one arm (intervention=TAVI) | There is not control group/arm for comparison. Receives: Device: Biological prosthesis in the aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of TAVI on all-cause mortality
To assess the long-term survival benefits of TAVI
Measured: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
The impact of TAVI on left ventriclar mass and hypertrophy regression
To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).
Measured: From January 2012 to follow-up echo (6-12 months following TAVI)
The impact of TAVI on left ventricular function recovery
To assess improvement in systolic function (increase in ejection fraction) following TAVI
Measured: From January 2012 to to follow-up echo (6-12 months following TAVI)
The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.
Measured: From January 2012 to to follow-up echo (6-12 months following TAVI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study startJan 2012
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahrai Saeed, MD.Ph.D., Principal investigator, Department of Heart Disease Haukeland University Hospital, Begen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417829
- Sponsor's protocol ID
- 2019/33814/REK vest
- Other IDs
- 2019
- Acronym
- TAVI-NOR
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Wasim D, Ali AM, Bleie O, Packer EJS, Eriksen E, Keilegavlen H, Rajani R, Rotevatn S, Saeed S. Prevalence and predictors of permanent pacemaker implantation in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a prospective cohort study. BMJ Open. 2025 Feb 7;15(2):e093073. doi: 10.1136/bmjopen-2024-093073.
PubMed 39920059Mohamed Ali A, Wasim D, Loland KH, Rotevatn S, Bleie O, Saeed S. Impact of transcatheter aortic valve implantation on left ventricular function recovery, mass regression and outcome in patients with aortic stenosis: protocol of the TAVI-NOR prospective study. BMJ Open. 2021 Jan 20;11(1):e039961. doi: 10.1136/bmjopen-2020-039961.
PubMed 33472776
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04417829
- Acronym / sponsor ID
- TAVI-NOR / 2019/33814/REK vest
- Conditions
- Aortic Stenosis, Hypertension
- Keywords
- Aortic stenosis, Echocardiography, Transcutaneous aortic valve implantation, Left ventricular dysfunction, Left ventricular hypertrophy, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.
Detailed description
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and July 2019.
Demographics, clinical data including cardiovascular risk factors, arterial and echocardiographic parameters were prospectively collected. The data on all-cause mortality will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at 6-12 months follow-up) will be analyzed. The main scientific objectives are:
To assess survival benefits of TAVI according to baseline risk profile. To determine the echocardiographic predictors of left ventricular mass regression and left ventricular function recovery.
To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the impact of various types of blood pressure responses immediately after TAVI on clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only one arm (intervention=TAVI) | – | Device: Biological prosthesis in the aortic valveThere is not control group/arm for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 600 patients with moderate or severe aortic stenosis of any etiology, and symptoms, where aortic valve intervention was clinially indicated. All patients underwent a successful TAVI (transcatheter aortic valve implantation).
Key inclusion criteria (4 listed)
- Hemodynamically severe aortic stenosis and symptoms
- A decision of TAVI by Heart team
- Patients undergoing TAVI (transcatheter aortic valve implantation)
- Life expectancy > 1-2 years
Key exclusion criteria (4 listed)
- Sever frailty
- Severly reduced cognitive function
- Multiple comorbid conditions
- Technically not suited for TAVI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological prosthesis in the aortic valveTranscatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated) | Device | Only one arm (intervention=TAVI) |
Primary outcome
The impact of TAVI on all-cause mortality
Time frame: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
To assess the long-term survival benefits of TAVI
The impact of TAVI on left ventriclar mass and hypertrophy regression
Time frame: From January 2012 to follow-up echo (6-12 months following TAVI)
To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).
The impact of TAVI on left ventricular function recovery
Time frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in systolic function (increase in ejection fraction) following TAVI
The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
Time frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 39920059Wasim D, Ali AM, Bleie O, Packer EJS, Eriksen E, Keilegavlen H, Rajani R, Rotevatn S, Saeed S. Prevalence and predictors of permanent pacemaker implantation in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a prospective cohort study. BMJ Open. 2025 Feb 7;15(2):e093073. doi: 10.1136/bmjopen-2024-093073.
- Derived from this study: PubMed 33472776Mohamed Ali A, Wasim D, Loland KH, Rotevatn S, Bleie O, Saeed S. Impact of transcatheter aortic valve implantation on left ventricular function recovery, mass regression and outcome in patients with aortic stenosis: protocol of the TAVI-NOR prospective study. BMJ Open. 2021 Jan 20;11(1):e039961. doi: 10.1136/bmjopen-2020-039961.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Human Experimental Models of Pain (HEMP)
Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahrai Saeed, MD.Ph.D. principal investigator
Department of Heart Disease Haukeland University Hospital, Begen, Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Hypertension, run by Haukeland University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of TAVI on all-cause mortality (time frame: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.