Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Class I or III Antiarrhythmic Medications · 1 trial · 1 indication
The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included: 1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes. 2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only) 3. The Investigator judged all procedures to be acutely successful (Ablation Management arm only).
The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.
The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ablation Management |
| 2 | ACTIVE_COMPARATOR | Medical Management |
| Name | Type | Description |
|---|---|---|
| Medtronic Cardiac Ablation System | PROCEDURE | Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed. |
| Class I or III Antiarrhythmic Medications | DRUG | Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. |
INCLUSION CRITERIA: * History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct ...
Class I or III Antiarrhythmic Medications are used for the treatment of Atrial Fibrillation. They are small molecule drugs being developed by Medtronic plc. The medications are intended to manage heart rhythm in patients with this condition, with a completed Phase 3 clinical trial evaluating their efficacy.
Medtronic plc (NYSE: MDT) is the developer of Class I or III Antiarrhythmic Medications. The company is conducting clinical research on these drugs for the treatment of Atrial Fibrillation, a cardiovascular condition. The development program includes a Phase 3 trial that has been completed.
Class I or III Antiarrhythmic Medications are in Phase 3 clinical development for Atrial Fibrillation. A Phase 3 trial has been completed, with 210 participants enrolled. The drug is investigational and not yet approved, as it remains in clinical development.
Class I or III Antiarrhythmic Medications have one completed Phase 3 clinical trial, NCT00514735, titled 'Tailored Treatment of Permanent Atrial Fibrillation'. This randomized, active-controlled study enrolled 210 participants in the United States and Netherlands, with a minimum age of 18 years.
Class I or III Antiarrhythmic Medications refer to a category of drugs that includes multiple specific agents. The clinical trial NCT00514735 evaluated tailored treatment approaches using these medications for permanent Atrial Fibrillation. No specific alternative names for the drug product were provided in the available information.