QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)
A legfontosabb adatok
- Hol
- Newmarket és Ottawa (Kanada)Mind a 2 helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat 18 év feletti, tartós pitvarfibrillációban (szabálytalan szívritmus) szenvedő felnőtteket keres. Az igazi kardioverziót egy színlelt (placebo) kardioverzióval hasonlítja össze, hogy lássa, hogyan változik az életminőség.
- Életkor
- 18 éves vagy idősebb
- Nem
- Mindkét nem csatlakozhat.
- A betegség stádiuma
- Tartós (perzisztáló) pitvarfibrilláció, a pitvarfibrillációhoz kapcsolódó tünetek mértéke nem ismert.
- Korábbi kezelés
- Aki átesett katéteres vagy sebészi pitvarfibrilláció-ablación, nem csatlakozhat.
A részvétel fő kizáró okai
- Ismert bal pitvari fülcse trombus (vérrög)
- Korábbi katéteres vagy sebészi ablatio pitvarfibrilláció miatt
- Amiodaron-intolerancia vagy ellenjavallat
- Megfelelő véralvadásgátlás ellenjavallata
- Terhesség vagy szoptatás
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Kanada
- Southlake HealthNewmarket, KanadaContact: Mouhannad Sadek, MDRésztvevőt keres
- University of Ottawa Heart InstituteOttawa, KanadaContact: Tammy KnightRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Ottawa Heart Institute Research Corporation
- Azonosító
- NCT05136131
- A regiszteradat frissítve
- 2026. július 1.
- Eredeti leírás
Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden.A teljes eredeti leírásKevesebb
Quality of Life Improvement After Cardioversion of Persistent AF - A Randomized Sham-Controlled Clinical Trial
Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden.
Rhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a "sham" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus "sham" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion.
Understanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.
Bevonási feltételek: Patients age ≥ 18 years; Persistent atrial fibrillation; Unknown symptom burden related to AF.
Kizáró feltételek: Prior catheter or surgical ablation for AF; Patient with a history of noncompliance with medical therapy; Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment); Known left-atrial appendage thrombus; Intolerance or contraindication to Amiodarone; Contraindication to appropriate anticoagulation; Patient is included in another randomized clinical trial; Patient is unable or unwilling to provide informed consent; Patient does not meet all of the above listed inclusion criteria; Breastfeeding; Patients for whom the investigator believes that the trial is not in the interest of the patient.