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Trial · NCT07897305

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecurrence of atrial arrhythmias at 12 months after a single ablation procedure without the use of any Class I/III antiarrhythmic drugs (AADs).From enrollment to the end of treatment at 52 weeks
Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).
PrimaryComposite serious adverse events (SAEs) occurring during the perioperative period and follow-up period.From enrollment to the end of treatment at 52 weeks
1. follow-up period, including cardiac tamponade/cardiac perforation, acute cerebrovascular events, acute coronary syndrome, pericarditis, acute kidney injury, third-degree atrioventricular block, serious bleeding events, atrial-esophageal fistula, pericardial-esophageal fistula, pulmonary vein stenosis, death, etc.; 2. Incidence of mazdutide-related adverse reactions, such as nausea/vomiting/diarrhea/abdominal pain, elevated serum calcitonin, elevated pancreatic enzymes, severe hypoglycemia, arrhythmia or conduction system disorders, severe liver function abnormality, severe renal function abnormality, thyroid C-cell hyperplasia or thyroid carcinoma, cholelithiasis, acute cholecystitis, cholecystectomy, severe hypersensitivity reactions, etc.
SecondaryRecurrence of atrial arrhythmias at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).From enrollment to the end of treatment at 52 weeks
Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) at 12 months after a single ablation procedure (after a 3-month blanking period), with or without the use of Class I/III AADs;
SecondaryRecurrence of AF at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).From enrollment to the end of treatment at 52 weeks
Recurrence of AF recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of Class I/III AADs;
SecondaryRecurrence of AT or AFL at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).From enrollment to the end of treatment at 52 weeks
Recurrence of atrial flutter or atrial tachycardia recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of Class I/III AADs;
SecondaryRecurrence of atrial arrhythmias after single or multiple ablations during the 12-month follow-upFrom enrollment to the end of treatment at 52 weeks"Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) after single or multiple ablations during the 12-month follow-up, with or without the use of Class I/III AADs;
SecondaryAF burdenFrom enrollment to the end of treatment at 52 weeksAF burden (% time) measured at the 12-month follow-up;
SecondaryBody weightFrom enrollment to the end of treatment at 52 weeksChanges in body weight in kilograms from baseline to the 12-month follow-up;
SecondaryApnea-Hypopnea IndexFrom enrollment to the end of treatment at 52 weeksChanges in Apnea-Hypopnea Index (AHI) from baseline to the 12-month follow-up;
SecondaryChange in Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) Score From Baseline to 12 MonthsFrom enrollment to the end of treatment at 52 weeks
The Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire will be used to assess quality of life. The AFEQT total score ranges from 0 to 120, with higher scores indicating better quality of life. Changes from baseline to the 12-month (52-week) follow-up will be reported.
SecondaryCardiovascular-related hospitalizationsFrom enrollment to the end of treatment at 52 weeksIncidence of cardiovascular-related hospitalizations during the 12-month follow-up;

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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