An observational study in Congenital Heart Disease, Congenital Heart Defect and Transposition of the Great Arteries, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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Among 18 studies in Heart Defects, Congenital with a site in Spain — 5 open to participants now, 6 under way, none of them phase 3. Heart Defects, Congenital · Spain.
Among the 18 studies in Heart Defects, Congenital with a site in Spain, this one is one of 2 that started in 2018, is one of 9 observational ones, and was the 10th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →5 of the 18 studies in Heart Defects, Congenital with a site in Spain are open now. Recruiting first, the newest first:
Fundacion para la Innovacion en Biomedicina (FIBMED) · Sites in Spain
Ages 18–80
Hospital Universitario 12 de Octubre · Sites in Spain, Sweden
Ages 16 wk–28 wk
Centro Medico Teknon · Sites in Spain
Ages 5–18
Queen Silvia Children's Hospital, Gothenburg, Sweden · Sites in Spain, United States, Austria and 5 more countries
Ages 23 wk–31 wk
Paragonix Technologies · Sites in Spain, United States, Austria and 1 more country
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2004; 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 25 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Median enrollment 84 across the 9 interventional studies, 200 across the 9 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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6 of 18 have an industry lead sponsor. The 10 most frequent:
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Hospital Universitari Vall d'Hebron Research Institute has 4 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
1 of the studies in Heart Defects, Congenital with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07425132Fundacion para la Innovacion en Biomedicina (FIBMED)Non-Invasive Electrocardiographic Imaging for Personalized Arrhythmia Care in Congenital Heart Disease | 2026-12 |
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Among the 18 studies in Heart Defects, Congenital with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cardiac denervation is inherent to the arterial switch (ASO) technique for the repair of transposition of the great arteries (TGA) and the long term reinnervation process has not been studied. We sought to describe the reinnervation status of adult patients long after the ASO, to identify areas of myocardial perfusion/innervation mismatch and to assess the relation of innervation status and exercise capacity.
Cardiac denervation is inherent to the arterial switch (ASO) technique for the repair of transposition of the great arteries (TGA) and the long term reinnervation process has not been studied. We sought to describe the reinnervation status of adult patients long after the ASO, to identify areas of myocardial perfusion/innervation mismatch and to assess the relation of innervation status and exercise capacity.
Patients aged of more than 18 years-old with transposition of the great arteries repaired with the arterial switch
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.
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.
patients with transposition of the great arteries long after repair with the arterial switch operation
Other: Non intervention
patients without intervention
Also known as: patients without intervention
Myocardial innervation pattern on 123I-mlBG SPECT.
To describe the myocardial reinnervation pattern of a cohort of patients with TGA long after ASO using cardiac nuclear imaging.
Time frame: 1 day
Myocardial perfusion defects on cardiac nuclear imaging.
To identify myocardial perfusion defects using cardiac nuclear imaging.
Time frame: 1 day
Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.
To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
Time frame: 1 day
Treadmill exercise test.
To determine exercise capacity (METs and double product) and chronotropic response (Maximal heart rate and heart rate increase pattern). Correlate with myocardial reinnervation pattern and sinus node reinnervation. To determine exercise induced ischeamic ST segment changes. Correlate with myocardial perfusion defects and innervation-perfusion mismatch.
Time frame: 1 day
24 hours ECG Holter monitoring .
To determine sinus node innervation through heart rate variability (HRV) which will be assessed by time domain variables (the standard deviation of normal RR intervals (SDNN) and the square root of the mean of the squared differences between adjacent normal RR intervals (r-MSSD)) and frequency domain variables (variance of all R-R intervals - total power (TP); power in the very low frequency range - very low frequency (VLF, 0.003-0.04 Hz); power in the low frequency range-low frequency (LF, 0.04-0.15Hz); low frequency power in normalized units-normalized low frequency; power in the high frequency range-high frequency (HF, 0.15-0.40 Hz); and high frequency power in normalized units-normalized high frequency and the ratio of low frequency to high frequency (LF/HF)).
Time frame: 1 day
Plan to share: No
Ran from Apr 2018 to primary completion in Mar 2019, 10 months.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's 10 months is below that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute →