Trial · NCT07897305
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence 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). |
| Primary | Composite 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. |
| Secondary | Recurrence 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; |
| Secondary | Recurrence 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; |
| Secondary | Recurrence 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; |
| Secondary | Recurrence of atrial arrhythmias after single or multiple ablations during the 12-month follow-up | From 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; |
| Secondary | AF burden | From enrollment to the end of treatment at 52 weeks | AF burden (% time) measured at the 12-month follow-up; |
| Secondary | Body weight | From enrollment to the end of treatment at 52 weeks | Changes in body weight in kilograms from baseline to the 12-month follow-up; |
| Secondary | Apnea-Hypopnea Index | From enrollment to the end of treatment at 52 weeks | Changes in Apnea-Hypopnea Index (AHI) from baseline to the 12-month follow-up; |
| Secondary | Change in Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) Score From Baseline to 12 Months | From 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. |
| Secondary | Cardiovascular-related hospitalizations | From enrollment to the end of treatment at 52 weeks | Incidence 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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