An observational study in Aortic Stenosis, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Istanbul University - Cerrahpasa · Observational
Among 14 studies in Aortic Valve Stenosis with a site in Turkey — 9 open to participants now, 9 under way, 2 of them phase 3. Aortic Valve Stenosis · Turkey.
Among the 14 studies in Aortic Valve Stenosis with a site in Turkey, this one is one of 2 that started in 2026, is one of 6 observational ones, and was the 14th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 52 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →9 of the 14 studies in Aortic Valve Stenosis with a site in Turkey are open now.
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 2 started in 2026.
Median enrollment 60 across the 8 interventional studies, 87 across the 6 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
3 of 14 have an industry lead sponsor. The 10 most frequent:
Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
Istanbul University - Cerrahpasa has 2 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Aortic Valve Stenosis with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07794436Istanbul University - CerrahpasaAssociation Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation | 2027-04 |
Among the 14 studies in Aortic Valve Stenosis with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
This prospective, single-center observational study aims to evaluate the relationship between changes in aortic valve hemodynamics and pulmonary congestion in patients undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis. Pulmonary congestion will be assessed non-invasively using lung ultrasound, with particular emphasis on B-lines, at predefined time points before and after TAVI. Changes in aortic valve area and other echocardiographic parameters will be evaluated in relation to changes in lung ultrasound findings. The primary objective is to determine the association between improvement in aortic valve area following TAVI and changes in pulmonary congestion.
Patients with severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI will be prospectively enrolled in this single-center observational cohort study. A total of 52 patients are planned to be included.
Pulmonary congestion will be assessed using standardized lung ultrasound examinations performed at predefined time points during the peri-procedural period. Lung ultrasound assessment will primarily quantify B-lines and will also document relevant findings such as pleural effusion and consolidation. Assessments will be performed before TAVI and repeated after the procedure to characterize temporal changes in pulmonary congestion.
Aortic valve hemodynamics, including aortic valve area, will be assessed by transthoracic echocardiography. The principal analysis will evaluate the relationship between the change in aortic valve area after TAVI and the corresponding change in lung ultrasound findings. In particular, the association between the change in aortic valve area and the change in lung ultrasound findings at 24 hours will be evaluated.
By integrating echocardiographic assessment of valve hemodynamics with serial lung ultrasound, the study aims to characterize the relationship between hemodynamic improvement following TAVI and early changes in pulmonary congestion.
The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Eligible patients will undergo echocardiographic and lung ultrasound assessments at predefined time points to evaluate changes in aortic valve hemodynamics and pulmonary congestion following TAVI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Lung ultrasound and echocardiographic assessments will be performed at predefined time points to evaluate changes in pulmonary congestion and aortic valve hemodynamics.
Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Transfemoral transcatheter aortic valve implantation (TAVI) performed as part of routine clinical care in patients with severe symptomatic aortic stenosis. The decision to perform TAVI and procedural management are independent of study participation. No modification of the TAVI procedure is made for research purposes.
Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
The primary outcome is the correlation between the change in aortic valve area (AVA), measured by transthoracic echocardiography and expressed in cm², and the change in total lung ultrasound (LUS) score after TAVI. Lung ultrasound will be performed at three time points: immediately before anesthesia (T1), immediately after TAVI (T2), and 24 hours after the procedure (T3). Both hemithoraces will be examined in 12 thoracic zones. Each zone will be scored from 0 to 3 according to the degree of loss of aeration: 0 = normal aeration, characterized by A-lines or fewer than 2 B-lines with lung sliding; 1 = mild alveolar-interstitial pattern, characterized by 3 or more well-spaced B-lines with lung sliding; 2 = severe alveolar-interstitial pattern, characterized by multiple crowded and coalescent B-lines occupying \>50% of the scanned intercostal space with lung sliding; and 3 = severe loss of aeration, characterized by a tissue-like pattern or consolidation. The scores from all 12 zones will
Time frame: From preprocedural baseline to 24 hours after TAVI
Change in B-Line Count After TAVI
Change in the total number of B-lines assessed by lung ultrasound from the preprocedural baseline to 24 hours after transcatheter aortic valve implantation (TAVI). B-lines will be assessed in predefined thoracic zones, and the change in B-line count following TAVI will be evaluated as a marker of change in pulmonary congestion.
Time frame: From preprocedural baseline to 24 hours after TAVI
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 13 months after the start.
Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 13 months is below that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
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Istanbul University - Cerrahpasa →