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NCT02637453
Addition of Six Short Lines on Pulmonary Vein Isolation
NA trial testing PVI in Paroxysmal Atrial Fibrillation in 390 participants. Completed in 10 January 2021.
10 January 2021
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 390 |
| Start date | 4 January 2017 |
| Primary completion | 10 January 2021 |
| Estimated completion | 10 January 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- PVI — full drug profile →
- CPVI+6L
Conditions studied
- Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 80, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
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 NCT02637453
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PVI
Trials testing the same drug.
- NCT07181291 — Pulsed Field or Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation in Heart Failure · completed
- NCT07122336 — Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation · NA · recruiting
- NCT06705842 — APPI-Cost Trial for Perforated Appendicitis · Phase 4 · recruiting
- NCT06825104 — Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation · recruiting
- NCT05908955 — Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation · NA · recruiting
Other recruiting trials for Paroxysmal Atrial Fibrillation
Currently open trials in the same condition.
- NCT07535268 — REPRESENT-PF Registry · recruiting
- NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
- NCT07281898 — Burst Stimulation for Paroxysmal Atrial Fibrillation · NA · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT06765356 — Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias · Phase 4 · active not recruiting
Other Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
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- NCT07375602 — A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children · recruiting
- NCT07405658 — Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Ear · not yet recruiting
- NCT07381400 — Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Stu · Phase 2 · not yet recruiting
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 NCT02637453 (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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 15 June 2021
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/NCT02637453.
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