Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646887
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PFA Champion
Brief Summary:
The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation AF called electroporation systems Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated The goal of this study is to determine which electroporation system is the most effective and safest for treating AF These systems work by using electrical energy to disrupt abnormal heart tissue helping to restore a normal heart rhythm
Detailed Description:
The investigators are testing three different electroporation systems Farapulse PulseSelect and Varipulse Each of these systems uses a similar approach to treat AF but they may work slightly differently The investigators want to find out which one is best at permanently stopping the irregular heart rhythm while also being the safest for patients
What will happen during the study
The patient will have two procedures
First procedure This is the initial ablation where the doctors will use one of the three electroporation systems to treat the atrial fibrillation During this procedure the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening
Second procedure After about 3 months the participant will return for a re-mapping procedure This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back If necessary the investigator will perform another ablation to correct any remaining problems
Is it safe All procedures are performed by experienced doctors who specialize in treating AF Like any medical procedure there are some risks such as small chances of blood clots injury to nearby tissues or complications from the anesthesia However the electroporation systems are designed to minimize these risks and the study will closely monitor your loved one for any complications
What are the benefits of participating The participant could benefit from receiving one of the latest treatments for atrial fibrillation By participating they will help doctors learn which system works best which could help future patients with similar conditions Additionally the participant heart rhythm will be closely monitored and if any problems arise they will receive immediate care
How long will it take The study will last about 6 to 7 months with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later
What will happen during the study
The patient will have two procedures
First procedure This is the initial ablation where the doctors will use one of the three electroporation systems to treat the atrial fibrillation During this procedure the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening
Second procedure After about 3 months the participant will return for a re-mapping procedure This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back If necessary the investigator will perform another ablation to correct any remaining problems
Is it safe All procedures are performed by experienced doctors who specialize in treating AF Like any medical procedure there are some risks such as small chances of blood clots injury to nearby tissues or complications from the anesthesia However the electroporation systems are designed to minimize these risks and the study will closely monitor your loved one for any complications
What are the benefits of participating The participant could benefit from receiving one of the latest treatments for atrial fibrillation By participating they will help doctors learn which system works best which could help future patients with similar conditions Additionally the participant heart rhythm will be closely monitored and if any problems arise they will receive immediate care
How long will it take The study will last about 6 to 7 months with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later
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