Symptomatic Aortic Valve Stenosis Clinical Trial
Official title:
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis
| Verified date | November 2013 |
| Source | Heinrich-Heine University, Duesseldorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethic Committee |
| Study type | Observational |
The development of a high grade AV-block is a frequent complication associated with
transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be
enrolled in this study. The HV-interval will be determined before and immediately after
implantation.
The hypothesis is that a prolonged HV-interval is associated with a high rate of complete
AV-block following TAVI.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - symptomatic aortic valve stenosis - patients screened for TAVI - written informed consent Exclusion Criteria: - unconsciousness, not able to consent - < 18 years - permanent pacemaker |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| Germany | Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf | Duesseldorf | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| Klinik für Kardiologie, Pneumologie und Angiologie |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | cardiovascular mortality | 1 month, 6 months and 12 months | Yes | |
| Primary | Determination of HV interval | HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation. | Changes in Baseline to 24 hours | Yes |
| Secondary | AV-block development after 1 month, 6 months and 12 months | 1 month, 6 months and 12 months | Yes |