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ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Zarina Habibi, MD
- Telefoonnummer: +31-43-3881200
- E-mail: ablatie.onderzoek@gmail.com
Studie Contact Back-up
- Naam: Dominique Verhaert, MD
- E-mail: ablatie.onderzoek@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 18 years of age or older;
- Documented atrial fibrillation;
- Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Conditions preventing the patient from adhering from the study protocol;
- Emergency procedures.
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
- Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
- Severe allergic reaction against body surface electrodes
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
• Status after esophageal or gastric surgery
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
• Contraindication to MRI
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
• Prior catheter or surgical AF ablation.
Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
- Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
- Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
- Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Ablation success
Tijdsspanne: 12 months
|
Freedom from documented recurrence of atrial arrhythmia after 12 months.
Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Time to recurrence of AF or other atrial arrhythmia after the blanking period.
Tijdsspanne: 3 to 24 months
|
Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.
|
3 to 24 months
|
Early recurrences of AF or other atrial arrhythmia
Tijdsspanne: 0 to 3 months
|
Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months
|
0 to 3 months
|
Number of participants with disease progression to persistent or permanent AF.
Tijdsspanne: 0 to 24 months
|
Disease progression to persistent or permanent AF.
Persistent AF is defined as AF that lasts longer than 7 days.
Permanent AF can't be corrected with treatments.
|
0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation.
Tijdsspanne: 0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation
|
0 to 24 months
|
Interleukin 6 (IL-6) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Pro-brain natriuretic peptide 2 (pro-BNP2) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Fibroblast growth factor 23 (FGF-23) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Dickkopf-related protein 3 (DKK-3) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Angiopoietin 2 (ANG-2) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Endothelial cell-specific molecule 1 (ESM-1) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Insulin-like growth factor-binding protein 7 (IGFBP-7) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Bone morphogenetic protein 10 (BMP-10) level
Tijdsspanne: 0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Redo procedures
Tijdsspanne: 0 to 24 months
|
Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.
|
0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
Tijdsspanne: 0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
|
0 to 24 months
|
Major adverse cardiovascular events (MACE).
Tijdsspanne: 0 to 24 months
|
Major adverse cardiovascular events (MACE).
|
0 to 24 months
|
Procedure time
Tijdsspanne: Intraoperative
|
Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).
|
Intraoperative
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kevin Vernooy, MD. PhD, Maastricht UMC+ & Radboudumc
- Hoofdonderzoeker: Dominik Linz, MD, PhD, Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen
- Hoofdonderzoeker: Ulrich Schotten, MD, PhD, Maastricht University & Cardiovascular Research Institute Maastricht
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NL80761.068.22
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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