Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. Radiofrequency catheter ablation (RFCA) are the effective treatment for patients with drug-refractory symptomatic paroxysmal or persistent AF. However, the successful rate of RFCA for persistent AF during the first procedure still relatively low, the investigators also need pharmacological cardioversion or external electrical conversion. Several studies showed intravenous nifekalant injection after RFCA provided relative high rate of sinus conversion during catheter ablation in paroxysmal or persistent AF. Nevertheless, there is still no acceptable universal opinion on which dosage of nifekalant is preferable for converting AF during the operation. In order to address this issue, the investigators initiated the study to evaluate the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Nanchang University
• Treatments: Nifekalant

Criteria

Inclusion Criteria:

• Documented symptomatic persistent or longstanding persistent AF

• An absence of response to, unacceptable side effects from, or unwillingness to take antiarrhythmic agents

• Willingness to receive combined ablation strategy, including bilateral circumferential pulmonary vein isolation and linear ablation

• Failure to terminate AF to after combined ablation strategy

• Willingness to receive intravenous treatment with nifekalant during the procedure

Exclusion Criteria:

• A history of nontraumatic intracerebral hemorrhage at any time

• Gastrointestinal bleeding within the past six months

• Major surgery within thirty days

• A known bleeding diathesis or coagulation disorder

• A confirmed thrombus in the left atrium by esophageal ultrasound

• Renal failure requiring dialysis

• Pregnant or lactating

• A left ventricular ejection fraction (LVEF) of 30% or less

• Ventricular tachycardia with prolonged QT interval

• Patients with QTc interval of more than 500 ms

• Torsades de pointes (Tdp), or Brugada syndrome