Aortic Valve Stenosis Clinical Trial
— PACE-TAVIOfficial title:
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry
The current observational registry aims to evaluate in patients undergoing TAVI implantation: 1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure, 2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation, 3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients in sinus rhythm with TAVI Exclusion Criteria: - Patients in atrial fibrillation at the time of the implantation - Patients with pre-existent pacemaker |
Country | Name | City | State |
---|---|---|---|
Belgium | Algemeen Stedelijk Ziekenhuis Aalst | Aalst | |
Belgium | OLV Aalst | Aalst | |
Belgium | ZNA Middelheim | Antwerp | |
Belgium | AZ Sint Jan | Brugge | |
Belgium | CHU Charleroi-Chimay | Charleroi | |
Belgium | Grand Hôpital de Charleroi | Charleroi | |
Belgium | Ziekenhuis Oost-Limburg | Genk | |
Belgium | UZ Brussel | Jette | |
Belgium | UZ Leuven | Leuven | |
Belgium | Citadelle Hospital | Liège | |
Belgium | Clinique Saint-Luc Bouge | Namur | |
Belgium | AZ Delta | Roeselare |
Lead Sponsor | Collaborator |
---|---|
AZ Sint-Jan AV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and negative predictive value of RAP for PPM implantation post TAVI | 1 month after TAVI | ||
Primary | Permanent pacemaker implantation | 1 month after TAVI | ||
Primary | New conduction abnormalities | within 1 week after TAVI | ||
Secondary | Duration of hospitalization | 1 month after TAVI | ||
Secondary | Echocardiographic changes | 1 month after TAVI | ||
Secondary | Stroke | 1 month after TAVI | ||
Secondary | Major vascular bleeding | 1 month after TAVI | ||
Secondary | New pericardial effusion | 1 month after TAVI | ||
Secondary | All-cause mortality | 1 month after TAVI |
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