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Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI

Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01801098
Enrollment
25
Registered
2013-02-28
Start date
2012-12-31
Completion date
2013-11-30
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Aortic Valve Stenosis

Keywords

TAVI, complete AV-block, HV-interval, permanent pacemaker

Brief summary

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.

Interventions

None listed

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* symptomatic aortic valve stenosis * patients screened for TAVI * written informed consent

Exclusion criteria

* unconsciousness, not able to consent * \< 18 years * permanent pacemaker

Design outcomes

Primary

MeasureTime frameDescription
Determination of HV intervalChanges in Baseline to 24 hoursHV-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.

Secondary

MeasureTime frame
AV-block development after 1 month, 6 months and 12 months1 month, 6 months and 12 months

Other

MeasureTime frame
cardiovascular mortality1 month, 6 months and 12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026