Trial · NCT04134845
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | 10 minutes post drug infusion | Post drug ventricular stimulation with Right Ventricle (RV) ventricular catheter in the Right Ventricle( RV) apex with increasing extra stimuli with planned decrement stimuli by 10 milliseconds (ms) to effective refractory period (ERP). Outcome is measured as Ventricular inducibility yes/no. |
| Secondary | Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | 10 minutes post drug infusion | A standardized induction protocol is performed using programmed ventricular stimulation from the Right Ventricular apex which was done pre-drug/placebo and post drug/placebo. The induction is single, double or triple extra beats of stimulation. |
| Other | Change in Heart Rate at 20 Minutes | 20 minutes | Heart rate measurement performed by standard heart rate monitors in the Electrophysiology lab. Difference between heart rate at 20 minutes post-drug infusion compared to pre-drug infusion. |
| Other | Change in Mean Arterial Blood Pressure | 20 minutes | Mean arterial blood pressure at 20 minutes vs pre-drug treatment |
| Other | Post-drug Arterial Oxygen Saturation | 20 minutes | Post-drug arterial oxygen saturation after 20 minutes as measured by arterial blood gas. |
| Other | Post-drug Mixed Venous O2 Sats- Measured From PA Catheter | 20 minutes | Hemodynamic monitoring for mixed venous O2 sats will be performed during ablation with a pulmonary artery (PA) catheter (aka. Swann-Ganz Catheter). Measurement obtained 20 minutes after drug administration. |
| Other | Mean PA Pressure | pre drug infusion and 20 minutes post drug infusion | Mean PA- mmHg; Hemodynamic monitoring for PA will be performed during ablation with pulmonary artery (PA) catheter (aka. Swann-Ganz Catheter). |
| Other | Serial Pulmonary Cap. Wedge Pressure Measurements | pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion | Measuring the Pulmonary Capillary Wedge pressure by the hemodynamic pulmonary catheter. |
| Other | Half-life | Up to 48 hours | The pharmacokinetic measurement of the time it takes for the concentration of the drug in the body to decrease by half. |
| Other | Maximum Observed Plasma Concentration | Up to 48 hours | A pharmacokinetic measure to determine the highest concentration of the drug. |
| Other | Time to Reach Maximum Observed Plasma Concentration | Up to 48 hours | Tmax (h) Time to maximum concentration by plasma concentration. |
| Other | Area Under the Concentration-time Curve From Zero to Infinity | Up to 48 hours | A measurement of pharmacokinetics which is the area under the curve measured as a function of time. |
| Other | Ventricular Effective Refractory Period Pre/Post Study Drug | 20 minutes | Ventricular effective refractory period measured via electrophysiology catheter from the RV apex. |
| Other | Respiratory Support | pre-procedure, during procedure, and two hours post procedure | Bag/mask ventilation, CPAP, BiPAP, LMA, or tracheal intubation |
| Other | Oxygen Saturation | pre-procedure, during procedure | Oxygen saturation measured by ABG, % |
| Other | Respiratory Rate | 20 minutes | Rate of respiration, respiration per minute pre drug and 20 minutes post-drug |
| Other | Minute Ventilation | 20 minutes | Ventilator measured L/min of ventilation measured pre-drug and 20 minutes post-drug |
| Other | Tidal Volume | 20 minutes | tidal volume pre drug and 20 minutes post drug |
| Other | Arterial Blood Gas - pH | 20 minutes | Blood gas, obtained from arterial blood supply, pH measurement pre-drug and 20 minutes post-drug. |
| Other | Arterial Blood Gas - pO2 | 20 minutes | Blood gas, obtained from arterial blood supply, mmHg of O2 concentration pre-drug and 20 minutes post-drug |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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