Clinical trial · Interventional
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation : Contribution of Electrophysioly Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients. The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS). In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure. After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing \> 1% ; presence of more than 1 AVB episod).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aortic Valve Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pacemaker SORIN Group KORA DR | Device | — | UNRESOLVED |
| transcatheter aortic valve implantation (TAVI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pacemaker
- description
- Patient who have been implanted with a pacemaker after TAVI
- interventionNames
- Device: Pacemaker SORIN Group KORA DR
- Procedure: transcatheter aortic valve implantation (TAVI)
- type
- ACTIVE_COMPARATOR
- label
- No Pacemaker
- description
- Patient who have not been implanted with a pacemaker after TAVI
- interventionNames
- Procedure: transcatheter aortic valve implantation (TAVI)
Primary outcomes (1)
- measure
- to confirm appropriate pacing indication in patients with conduction disorders after TAVI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * patient undergoing TAVI through femoral approach * age \> 50 years * informed and written consent * patient with social security system Exclusion criteria: * patient with previous pacemaker or ICD * patient under guardianship or curatorship * patient protected by law
References
Publications (0)
Data not yet available