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Flecainide for Congenital Heart Disease
N/A
Waitlist Available
Led By Audrey Dionne, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged < 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia >10%
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test whether a medication called Flecainide can prevent abnormal heart rhythms in children after cardiac surgery.
Who is the study for?
The PRECISION study is for children under 18 who've had heart surgery and are at risk of developing a fast heartbeat called supraventricular tachycardia. It's not for those with certain heart block conditions, on antiarrhythmic drugs, or with severe ventricular issues where specific medications are unsuitable.Check my eligibility
What is being tested?
This study tests if a special heart test (provocative electrophysiology study) can predict and prevent dangerous heart rhythms in kids after cardiac surgery, instead of just treating them when they happen.See study design
What are the potential side effects?
While the description doesn't specify side effects, procedures like an electrophysiology study may cause discomfort, bleeding or bruising at the catheter site, irregular heartbeats, or more rarely serious complications like blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Children under 18 years old who have a high chance of getting a specific fast heart rhythm after heart surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with supraventricular tachycardia
Secondary outcome measures
Number of days in the hospital
Number of days post-operatively at time of extubation
Number of days post-operatively in the intensive care unit
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TestingExperimental Treatment1 Intervention
Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced.
Group II: ObservationActive Control1 Intervention
Patients will be observed for arrhythmias and treated if they occur.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
763 Previous Clinical Trials
5,580,583 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,580 Total Patients Enrolled
The Children's Heart FoundationOTHER
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't have functional wires for pacing in your heart.You have severe heart ventricle problems and cannot take beta-blocker or sotalol medication.You have had a heart transplant, a ventricular assist device implanted, a pacemaker or implantable defibrillator implanted, or a sympathectomy.You are taking medication for irregular heartbeats at the time of surgery.Children under 18 years old who have a high chance of getting a specific fast heart rhythm after heart surgery.You have a type of heart condition that affects the electrical signals in your heart.
Research Study Groups:
This trial has the following groups:- Group 1: Observation
- Group 2: Testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this empirical study?
"Affirmative. Clinical trials data reveals that this study is currently recruiting participants, with the trial first being posted on March 23rd 2021 and last updated on September 7th 2022. 130 individuals are needed from 1 specified site."
Answered by AI
Who is most likely to be suitable for this experimental effort?
"Apposite to this research, individuals afflicted with congenital heart defects aged 0-18 are eligible for enrolment. There is presently a need of 130 participants in total."
Answered by AI
Are there still enrolments open for this research investigation?
"That is correct. According to clinicaltrials.gov, this study was first advertised on March 23rd 2021 and has since been updated in September of 2022. It requires 130 candidates from a single medical centre for successful completion."
Answered by AI
Is geriatric recruitment being included in this experimental trial?
"The entry requirements for this research study necessitate that all participants are between 0 and 18 years of age. On clinicaltrials.gov, there is a total of 94 studies enrolling children in this age range as well as 268 trials available to those over 65."
Answered by AI
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