TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
Completed
- Conditions
- Risk ScorePacemakerTAVI
- Interventions
- Device: TAVI, pacemaker
- Registration Number
- NCT06542380
- Lead Sponsor
- German Heart Institute
- Brief Summary
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020
Exclusion Criteria
- previous device implantation
- valve-in-valve procedure
- patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing TAVI at DHZC 2019-2021 TAVI, pacemaker -
- Primary Outcome Measures
Name Time Method Pacemaker Implantation 30 days after TAVI Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Deutsches Herzzentrum der Charité
🇩🇪Berlin-Mitte, Berlin, Germany