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NCT03443232
Effect of Catheter Ablation on Left Atrial Function in Persistent Atrial Fibrillation
NA trial testing Cryoballoon ablation in Persistent Atrial Fibrillation in 106 participants. Completed in 17 March 2020.
17 March 2020
Quick facts
| Lead sponsor | The Second Hospital of Hebei Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 16 February 2018 |
| Primary completion | 17 March 2020 |
| Estimated completion | 17 March 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cryoballoon ablation
- Radiofrequency ablation
Conditions studied
- Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Sponsor
The Second Hospital of Hebei Medical University
Who can join
Under 80, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into two groups. These patients will receive cryoballoon ablation, radiofrequency ablation under the guidance of 3D mapping respectively (allocation ratio, 1:1). Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation. Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation.This study will clarify whether these different operation methods have different effects on the recovery of postoperative left atrial function and electrical activity in patients with persistent atrial fibrillation, and whether changes in left atrial function electrical activity are related to indicators such as inflammation, blood clotting and myocardial injury. Cryoballoons ablation is still less used to operate on persistent atrial fibrillation. To investigate the ablative effect, electrical remodeling and structural remodeling of persist atrial fibrillation with different operating methods. Therefore, the ablation is related indicators such as the success rate of the operation, intraoperative complications, postoperative recurrence rate and the amount of x-ray exposure are compared among two groups. At the same time, biochemical indicators of inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme, BNP, troponin I and D-D dimmer are detected to analyze and determine which indicators are related to the postoperative recurrence of atrial fibrillation, the recovery of postoperative left atrial function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03443232
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- ASCO Meeting Library
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Related trials
Other trials of Cryoballoon ablation
Trials testing the same drug.
- NCT04269785 — Inflammatory and Endothelial Function Response, and Arrhythmia Recurrence Following Catheter Ablation for Atrial Fibrill · NA · withdrawn
- NCT04342832 — Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation · NA · terminated
- NCT03564925 — Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation · NA · unknown
- NCT03700307 — Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs o · NA · completed
- NCT03636100 — Release of Acetylcholine From the Ganglionated Plexus During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RE · terminated
Other recruiting trials for Persistent Atrial Fibrillation
Currently open trials in the same condition.
- NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
- NCT07535268 — REPRESENT-PF Registry · recruiting
- NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · NA · recruiting
Other The Second Hospital of Hebei Medical University trials
Trials by the same sponsor.
- NCT07117422 — Venetoclax-Decitabine in Untreated Elderly/Unfit AML · NA · recruiting
- NCT06248242 — Treatment of Acute Ischemic Stroke With Rt-PA Combined With Edaravone Dexborneol · Phase 4 · unknown
- NCT04524780 — Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appenda · NA · unknown
- NCT04524741 — Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appenda · NA · unknown
- NCT05930262 — Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03443232 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Hospital of Hebei Medical University
- Last refreshed: 18 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03443232.
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