An observational study in Aortic Valve Stenosis and Coronary Artery Disease, sponsored by Örebro County Council. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Örebro County Council · Observational
Among 38 studies in Aortic Valve Stenosis with a site in Sweden — 11 open to participants now, 17 under way, none of them phase 3. Aortic Valve Stenosis · Sweden.
Among the 38 studies in Aortic Valve Stenosis with a site in Sweden, this one is the 9th largest by enrollment of the 19 observational ones that give a count, is one of 2 that started in 2018, is one of 19 observational ones, and was the 23rd registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
Browse Aortic Valve Stenosis studies →11 of the 38 studies in Aortic Valve Stenosis with a site in Sweden are open now. Recruiting first, the newest first:
Copenhagen University Hospital, Rigshospitalet · Sites in Sweden, Denmark
Ages 18+
Ole De Backer · Sites in Sweden, Belgium, Denmark and 3 more countries
Ages 18+
Vastra Gotaland Region · Sites in Sweden
Vastra Gotaland Region · Sites in Sweden
Ages 65+
Abbott Medical Devices · Sites in Sweden, Australia, France and 8 more countries
Ages 18–100
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
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: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 346 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Median enrollment 135 across the 19 interventional studies, 300 across the 19 observational. Of the 19 that completed or were terminated, 4 (21%) have results posted.
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12 of 38 have an industry lead sponsor. The 10 most frequent:
Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.
Örebro County Council has 1 study filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
2 of the studies in Aortic Valve Stenosis with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT06008080Abbott Medical DevicesPost-Market Clinical Follow Up Study With Navitor Valve | 2027-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 38 studies in Aortic Valve Stenosis with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.
A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.
Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.
Patients that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.
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Exclusion Criteria:
No prior coronary intervention and no significant stenosis noted during coronary angiography.
Our definition of coronary artery disease is: * Prior coronary artery bypass grafting or percutaneous coronary intervention * Significant stenosis or occlusion noted during coronary angiography
Other: Coronary artery disease
Exposure
Mortality
Death after the procedure
Time frame: Five years.
Factors associated with less favorable early and late mortality
Factors such as renal function or comorbidities associated with higher mortality.
Time frame: Five years
Ran from Dec 2018 to primary completion in Dec 2020, 24 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Örebro County Council