Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481137
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-19
Brief Title:
Reversibility of Cardiac Conduction Disturbances Following TAVI
Sponsor:
Institut dInvestigació Biomèdica de Bellvitge
Organization:
Institut dInvestigació Biomèdica de Bellvitge
Study Overview
Official Title:
InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis The TAVI-REVERSE Study
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:
TAVI-REVERSE
Brief Summary:
The management of patients with conduction disturbances CDs after transcatheter aortic valve implantation TAVI is unclear especially in those with de novo electrocardiographic CDs ECG-CDs such as left bundle branch block
In this study the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study EPS 3-7 days following TAVI In addition the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI
In this multicenter longitudinal prospective study patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days Additionally these patients will undergo 4-week continuous monitoring using the ePatch Philips long-term Holter recorder to identify episodes of paroxysmal complete atrioventricular block Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks
In this study the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study EPS 3-7 days following TAVI In addition the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI
In this multicenter longitudinal prospective study patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days Additionally these patients will undergo 4-week continuous monitoring using the ePatch Philips long-term Holter recorder to identify episodes of paroxysmal complete atrioventricular block Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2300310 | OTHER_GRANT | None | None |