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

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ClinicalTrials.gov Identifier: NCT04209959
Recruitment Status : Enrolling by invitation
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Nanchang University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: nifekalant Phase 4

Detailed Description:

Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. Its prevalence increases with advanced age. About one percent of patients suffering from AF are younger than sixty years, twelve percent are between seventy-five and eighty-five years, and about thirty-three percent are older than eighty years. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. At present, the medical anti-arrhythmic therapy and radiofrequency ablation have been as important treatment for patients with AF. Compared with the treatment of anti-arrhythmia therapy, radiofrequency ablation could significantly improve the rate of long-term AF-free survival. Thus, radiofrequency ablation has become the radical method for patients suffering AF.

However, the successful rate of first radiofrequency ablation for patients with persistent AF was only about 65%. Due to low sinus maintenance rate after catheter ablation, anti-arrhythmic drugs (AADs) or external electric cardioversion was used to converting atrial fibrillation during the procedure. Compared with traditional AADs for pharmacologic cardioversion, such as quinidine, propafenone and amiodarone, nifekalant is a new class III AADs for rapid cardioversion of persistent AF during radiofrequency ablation, and its prevalence of AF termination during procedure was approximately 64.6%. Nevertheless, the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation has not been tested in large, randomized, controlled trials, and guidelines provide no clear consensus regarding the best dose recommended.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation:a Single-center Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low dose group Drug: nifekalant
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.

Experimental: middle dose group Drug: nifekalant
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.

Experimental: high dose group Drug: nifekalant
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.




Primary Outcome Measures :
  1. Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation [ Time Frame: up to 12 months ]
    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.

  2. 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. [ Time Frame: up to 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209959


Locations
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China, Jiangxi
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
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Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT04209959    
Other Study ID Numbers: 2014[023]
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Nifekalant
Anti-Arrhythmia Agents