Építés alatt – nem éles oldal
Belépés

NCT06039722Befejeződött

Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation

Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 19.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes： 1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. 2. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100% 3. Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100% Secondary evaluation indexes： 1. The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery; 2. Device performance evaluation; Safety evaluation indexes： 1. The occurrence of death, stroke, or transient ischemic attack; 2. The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc; 3. Clinically significant vital signs and related examinations; 4. The occurrence of other adverse events and serious adverse events during the trial period.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
166 (tényleges)
Első benyújtás
2023. szept. 10.
Kezdés
2022. nov. 3.
Elsődleges befejezés
2024. aug. 29.
Fő szponzor
Shenzhen Pulsecare Medical Technology Co., Ltd.
NCT-szám
NCT06039722

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 166
  • 2022. nov. 3. és az elsődleges befejezés (2024. aug. 29.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Patients who need to undergo left atrial appendage closure in the same surgery
  • Patients who have participated in a clinical trial of another drug or medical device within 3 months

Más betegség

  • Subjects were excluded if they met one of the following conditions:
  • Patients with cardiac function class (NYHA) III-IV
  • Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
  • Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
  • Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
  • Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
  • Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
  • Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
  • Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
  • Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months

Laborértékek

  • Patients with left ventricular ejection fraction (LVEF) <35%.

Egyéb

  • Patients who have had ablation for atrial fibrillation
  • Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm
  • Preoperative detection of a definite thrombus in the left atrium
  • Patients with second-degree (type II) or third-degree atrioventricular block
  • Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
  • Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures
  • Females who are pregnant or breastfeeding or who are planning to have children during the study period
  • Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial

Kiket keres a vizsgálat

  • Subjects must meet all of the following conditions to be enrolled:
  • 18 to 80 years of age, gender is not limited
  • Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
  • Patients who were to undergo catheter ablation of atrial fibrillation
  • Those who agreed to participate in this study and voluntarily signed the informed consent form

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）GuangzhouKínaIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Kapcsolódó publikációk

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.