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Search / Trial NCT03448562

CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 26, 2018

Trial Information

Current as of June 22, 2025

Unknown status

Keywords

Atrial Fibrillation Pulmonary Vein Isolation Catheter Ablation Substrate Modification

ClinConnect Summary

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, which affects patients' morbidity and mortality. AF ablation has emerged as a promising treatment strategy, offering the possibility of a durable treatment. Currently, there is no general agreement regarding NPAF ablation strategy. Obviously, pulmonary vein isolation is the corner stone for all types of AF ablation. The consensus is that CPVI alone is insufficient for NPAF ablation. However, the recent clinical trials did not show the additional benefits of other substrate modification strategies. Furthermore, ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients age is 18-80 years;
  • Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
  • Patients can sign the written informed consent for the study;
  • Patients can endure the required follow-up.
  • Exclusion Criteria:
  • Patients with previous radiofrequency ablation;
  • Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
  • Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
  • Patients with thromboemboli in LA (TEE or MSCT);
  • Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
  • Patients with abnormal thyroid function;
  • Patients with severe liver or renal dysfunction (AST or ALT \> 3-fold of upper limit value; the SCr \> 3.5 mg/dl or Ccr \< 30 ml/min);
  • Previous surgery history in last 3 months;
  • Patients with life expectancy \< 12 months; and
  • Patients who are pregnant.

About The First Affiliated Hospital With Nanjing Medical University

The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.

Locations

Nanjing, Jiangsu, China

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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