Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
nifekalant
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- The Second Afiliated Hospital of Nanchang University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
low dose group
middle dose group
high dose group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04209959
First Posted
December 3, 2019
Last Updated
December 23, 2019
Sponsor
Second Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT04209959
Brief Title
Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose group
Arm Type
Experimental
Arm Title
middle dose group
Arm Type
Experimental
Arm Title
high dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nifekalant
Intervention Description
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 Measure Information:
Title
Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation
Description
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.
Time Frame
up to 12 months
Title
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.
Description
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.
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Second Afiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation
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