- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07574931
Outcome of Ablation of Tachyarrhythmias in Patients With Congenital Heart Diseases
Studieoversikt
Status
Detaljert beskrivelse
This is a prospective cohort observational study including patients with CHD undergoing attempted catheter ablation.Baseline information is collected before catheter ablation. Data include demographic characteristics (age, gender), type of CHD, dates and types of previous cardiac surgeries, comorbidities, Electrocardiographic (ECG) and ECG recordings Holter (24h to 7 days) during tachycardia to document arrhythmia type and the presence of resting pre-excitation, palpitations attacks (frequency, duration, ICU / ER admission, ECG and mode of termination), history of supraventricular and ventricular arrhythmias, pharmacological therapy, previous catheter ablation and cardiac imaging (echocardiography with or without cardiac magnetic resonance imaging or cardiac computed tomography).
RF catheter ablation is performed after obtaining informed consent from all patients. Antiarrhythmic medication is in most cases discontinued for at least five half-lives before the procedure. Prepping and draping are performed according to standard hospital protocols under complete local aseptic conditions. Variable sized sheaths are introduced percutaneously via the right/left femoral/Jugular/ subclavian vein. Under fluoroscopic guidance, three electrode catheters are positioned as follows: at the high right atrium, from the His bundle region to the right ventricle, and in the coronary sinus (CS) ostium region. Bipolar intracardiac electro grams filtered between 30 and 500 Hz along with the 12- lead surface ECG were simultaneously recorded and stored digitally on a computerized multichannel EP recording system. Cases are filtered according to complexity and availability of 3D to conventional group for simple cases where RF ablation will be done guided by Conventional fluoroscopic guidance and for complicated cases RF ablation is guided by 3d electro anatomical mapping system.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt, 11956
- Cairo university hospitals
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia
- Patients with congenital heart diseases without documented arrhythmia but frequent palpitations.
Exclusion Criteria:
- Pregnant
- Patients with unstable hemodynamics
- End stage diseases e.g.: cancer stage IV
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Patients with congenital heart diseases with arrhythmia
Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia or without documented arrhythmia but frequent palpitations.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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the rate of acute success of catheter ablation
Tidsramme: From timing of catheter ablation till about one hour
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defined as termination of the clinical arrhythmia with non-inducibility of this clinical arrhythmia during Catheter ablation
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From timing of catheter ablation till about one hour
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rate of recurrence of tachyarrhythmias after catheter ablation
Tidsramme: one year
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one year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The types of Tachyarrhythmia in patients with congenital heart diseases
Tidsramme: One year
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One year
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D366
Plan for individuelle deltakerdata (IPD)
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