Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622772
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficiency of a device for terminating supraventricular tachycardia The main questions it aims to answer are
The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia but the success rate is low Can the device help to increase the sucess rate Whether the device is effective and safe to use at home Researchers will compare whether the device is more effective than a standard Valsalva manoeuvre to treat supraventricular tachycardia
Participants will
be randomly assigned 11 to a standard Valsalva manoeuvre group control or Valsalva manoeuvre with the device intervention
The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia but the success rate is low Can the device help to increase the sucess rate Whether the device is effective and safe to use at home Researchers will compare whether the device is more effective than a standard Valsalva manoeuvre to treat supraventricular tachycardia
Participants will
be randomly assigned 11 to a standard Valsalva manoeuvre group control or Valsalva manoeuvre with the device intervention
Detailed Description:
- Quality control and quality assurance Over the first month of the trial clinical investigators will come off-line for active participation once all local regulatory requirements have been met Training for Valsalva manoeuvre procedure data collection and reporting must be completed Endpoint and Adverse Event Committee will be installed comprising of medical experts who are not involved in the study
Periodic monitoring visits will be made throughout the clinical study to assure that the Investigator obligations are fulfilled and all applicable regulations and guidelines are being followed Key variables demographics inclusionexclusion criteria and safety on the CRFs will be compared with each subjects source documents Any discrepancies will be noted and resolved
The auditor will check potential problems evaluating whether their study implementation data collection and data analysis are in accordance with the protocol Manual of procedure MOP and good clinical practice GCP guidelines CRFs source documents and other study files must be accessible at all study sites at the time of auditing and inspection during the course of the study and after the completion of the study
- Sample size To calculate the required sample size we estimated that the standard Valsalva manoeuvre would cause cardioversion in 20 of patients with supraventricular tachycardia on the basis of local audit data and previous studies In our pro-protocol study 40 patients were included and the conversion rate of Valsalva manoeuvre with device to supraventricular tachycardia was 50 We powered our study to be able to detect at least a 20 absolute improvement with the modified Valsalva manoeuvre using the available evidence and the minimum improvement we thought would effect a change in practice We estimated that this difference would require 106 patients per group assuming a two-tailed test of statistical significance with an α of 005 and power of 09 and a 12 months recruitment period in our center
- Statistical Analysis Participants were analysed according to intention to treat and endpoints will be attributed to the treatment arm to which the patients were randomized regardless of treatment crossover or post-randomization medical care The statistical analysis will be carried out in accordance with the pre-designed We compared binary outcomes including the primary outcome and the secondary outcome using mixed effects logistic regression with allocation group as a fixed effect and clinicians as a random effect
Periodic monitoring visits will be made throughout the clinical study to assure that the Investigator obligations are fulfilled and all applicable regulations and guidelines are being followed Key variables demographics inclusionexclusion criteria and safety on the CRFs will be compared with each subjects source documents Any discrepancies will be noted and resolved
The auditor will check potential problems evaluating whether their study implementation data collection and data analysis are in accordance with the protocol Manual of procedure MOP and good clinical practice GCP guidelines CRFs source documents and other study files must be accessible at all study sites at the time of auditing and inspection during the course of the study and after the completion of the study
- Sample size To calculate the required sample size we estimated that the standard Valsalva manoeuvre would cause cardioversion in 20 of patients with supraventricular tachycardia on the basis of local audit data and previous studies In our pro-protocol study 40 patients were included and the conversion rate of Valsalva manoeuvre with device to supraventricular tachycardia was 50 We powered our study to be able to detect at least a 20 absolute improvement with the modified Valsalva manoeuvre using the available evidence and the minimum improvement we thought would effect a change in practice We estimated that this difference would require 106 patients per group assuming a two-tailed test of statistical significance with an α of 005 and power of 09 and a 12 months recruitment period in our center
- Statistical Analysis Participants were analysed according to intention to treat and endpoints will be attributed to the treatment arm to which the patients were randomized regardless of treatment crossover or post-randomization medical care The statistical analysis will be carried out in accordance with the pre-designed We compared binary outcomes including the primary outcome and the secondary outcome using mixed effects logistic regression with allocation group as a fixed effect and clinicians as a random effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None