Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO)
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO): a Vanguard Study
This study looks at participants who have undergone an ablation procedure for atrial fibrillation previously, and atrial fibrillation has occurred and a second ablation procedure is needed. The study will randomize participants to either a tailored strategy for ablation or to widening the pulmonary vein isolation procedure with or without cavotricuspid isthmus ablation. The goal is to improve freedom from recurrent atrial arrhythmias at 12 months.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a study of patients who have undergone an ablation procedure for AF but in whom AF recurred and who are undergoing a second ablation procedure. Specifically, the investigators are interested in the group of patients whose PVs are still "isolated" during that second procedure because doctors are unsure of how best to ablate them. It is even possible that doing any more ablation in those patients is harmful.
The study will compare (1) an ablation strategy that includes commonly done ablation steps that tackle abnormalities found during the procedure (i.e., ablating "low voltage areas", searching for and ablating other arrhythmias called supraventricular tachycardias, and in some patients ablating the "posterior wall") to (2) an ablation strategy that reinforces or extends the PVI step only. In both groups, cavotricuspid isthmus ablation is also performed, if not already successfully done previously. The vanguard study will follow participants for 1 year, with a 3 year follow up planned if feasibility is met. Participants will be required to wear a Holter monitor at various timepoints and will be asked to complete atrial fibrillation and quality of life questionnaires.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tammy Knight
- Telefonnummer: 613-696-7000
- E-post: TKnight@ottawaheart.ca
Studiesteder
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
Underetterforsker:
- David Birnie, MD
-
Ta kontakt med:
- Tammy Knight
- Telefonnummer: 613-696-7000
- E-post: tknight@ottawaheart.ca
-
Hovedetterforsker:
- F. Daniel Ramirez, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Paroxysmal atrial fibrillation with durable pulmonary vein isolation (PVI)
- Age >/= 18 years
- at least one episode of atrial fibrillation documented on 12-lead ECG, Holter monitor, or loop recorder in the preceding 12 months
- ability to provide informed consent
Exclusion Criteria:
- Persistent atrial fibrillation
- documented sustained atrial tachycardia or atypical atrial flutter.
- Previous atrial ablation excluding PVI or cavotricuspid Isthmus (CTI) ablation (having undergoing more than one procedure is acceptable as long as only PVI +/- CTI ablation was preformed)
- previous left atrial surgery
- known PV stenosis or history of PV intervention
- active intracardiac thrombus
- contraindication to systemic anticoagulation
- hypertrophic cardiomyopathy
- significant left-sided valve disease (moderate or severe mitral or aortic stenosis or regurgitation)
- significant congenital heart disease, including atrial septal defects or PV abnormalities (patent foramen ovale is not an exclusion)
- active pregnancy
- participation or anticipated participation in another clinical trial that could affect the results of this trial
- unwillingness or inability to adhere fully with study procedures and follow up
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tailored Strategy
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
|
Annen: Control Strategy
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Freedom from recurrent atrial arrhythmia lasting >/= 30 seconds
Tidsramme: Days 57 to 365 from repeat procedure.
|
Atrial arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia. |
Days 57 to 365 from repeat procedure.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Procedure duration
Tidsramme: From beginning of vascular access to removal of all catheters
|
Time, in minutes, of the repeat procedure |
From beginning of vascular access to removal of all catheters
|
|
Composite of major procedure-related complications
Tidsramme: Baseline to 12 months
|
Procedure-related complications include embolic events, pulmonary vein stenosis, cardiac perforation, major bleeding, atrioesophageal fistula, or death) |
Baseline to 12 months
|
|
Emergency Room visits or re-hospitalizations
Tidsramme: Baseline to 12 months
|
Visits and admissions related to recurrent atrial arrhythmias |
Baseline to 12 months
|
|
Repeat Catheter Ablation procedure
Tidsramme: Baseline to 12 months
|
Occurrence of additional ablation after the study index procedure. |
Baseline to 12 months
|
|
Atrial Fibrillation Effect on Quality of Life
Tidsramme: Baseline to 12 months.
|
Measured by the Atrial Fibrillation Effect on Quality of Life questionnaire. Scale of 0-100, with 100 being best quality of life. |
Baseline to 12 months.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: F. Daniel Ramirez, MD, Ottawa Heart Institute Research Corporation
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20260577-01H
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