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

NCT04209959 | Unknown Phase 4

• 1 other identifier: 2014[023]
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation

  Participants are randomized to one of three groups: low dose group (0.3mg/kg), middle dose group (0.4mg/kg), or high dose group (0.5mg/kg). The successful rates of different doses of nifekalant instant cardioversion were reported in terms of count and percentage, respectively.

  up to 12 months

• The occurrence of adverse events, including sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs and intracardiac electrograms within 30 minutes among different treatment groups.

  The occurrence of adverse events, such as sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs were represented in terms of count and percentage, respectively.

  up to 12 months

Study Arms (3)

low dose group

EXPERIMENTAL

Drug: nifekalant

middle dose group

EXPERIMENTAL

Drug: nifekalant

high dose group

EXPERIMENTAL

Drug: nifekalant

Interventions

nifekalant DRUG

Nifekalant was randomly given intravenously as a loading dose of 0.3 mg/kg, 0.4 mg/kg, or 0.5 mg/kg for five minutes without the continuous infusion for all study population, while blood pressure, surface electrocardiograms (ECG), intracardiac electrograms were monitored for half an hour. While nifekalant was given intravenously, QT interval, QTc interval and RR interval were recorded at 0, 1, 3, 5, 10, 15, 20 and 30minutes, respectively, because drug action almost disappeared within 30minutes since a single dose of intravenous nifekalant injection. These doses of nifekalant were determined based on the results of the previous study and the medicine operation instruction. Once AF continued after administration or Torsade de points was observed, external electrical cardioversion was given immediately.

high dose group; low dose group; middle dose group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Afiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

nifekalant

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 24, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)