Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299514
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-03-01
Brief Title:
RAFT-PA Randomized Control Trial
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Resynchronization for Ambulatory Heart Failure Trial in Patients with Chronic Atrial Fibrillation - Pharmacological Rate Control Vs Pace and Ablate with Conduction System Pacing
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atrial fibrillation AF is an irregular heartbeat that can cause symptoms of skipped beats shortness of breath stroke or in some cases fluid in the lungs or legs Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy In some cases slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments In those instances there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular AV node Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers the ventricles resulting in a slow rhythm Therefore if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker
A complex pacemaker that stimulates both the right and left ventricles simultaneously BiVP has been used for the last decade prior to AV node ablation More recently a technique has been designed to reduce the number of leads in the heart reduce procedure time and have a similar effect on the heart called Conduction System Pacing CSP There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF
A complex pacemaker that stimulates both the right and left ventricles simultaneously BiVP has been used for the last decade prior to AV node ablation More recently a technique has been designed to reduce the number of leads in the heart reduce procedure time and have a similar effect on the heart called Conduction System Pacing CSP There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None