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

Completed

• Conditions: Symptomatic Aortic Valve Stenosis

• Registration Number: NCT01801098
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• unconsciousness, not able to consent
• < 18 years
• permanent pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of HV interval	Changes in Baseline to 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
AV-block development after 1 month, 6 months and 12 months	1 month, 6 months and 12 months

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, NRW, Germany