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

This study is currently recruiting participants.

Verified February 2013 by Heinrich-Heine University, Duesseldorf

Sponsor:

Information provided by (Responsible Party):

Klinik für Kardiologie, Heinrich-Heine University, Duesseldorf

ClinicalTrials.gov Identifier:

NCT01801098

First received: February 6, 2013

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2013

Last Updated Date

February 26, 2013

Start Date ^ICMJE

December 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determination of HV interval [ Time Frame: Changes in Baseline to 24 hours ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01801098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AV-block development after 1 month, 6 months and 12 months [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

cardiovascular mortality [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.

Condition ^ICMJE

Symptomatic Aortic Valve Stenosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

symptomatic aortic valve stenosis
patients screened for TAVI
written informed consent

Exclusion Criteria:

unconsciousness, not able to consent
< 18 years
permanent pacemaker

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Malte Kelm, MD	0049 211 81 18800	Kardiologie@med.uni-duesseldorf.de
Contact: Marc W. Merx, MD	0049 211 81 18800	Kardiologie@med.uni-duesseldorf.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01801098

Other Study ID Numbers ^ICMJE

HV-interval prior TAVI

Has Data Monitoring Committee

Responsible Party

Klinik für Kardiologie, Heinrich-Heine University, Duesseldorf

Study Sponsor ^ICMJE

Klinik für Kardiologie

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Malte Kelm, MD	Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Principal Investigator:	Marc W. Merx, MD	Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf
Principal Investigator:	Dong-In Shin, MD	Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Information Provided By

Heinrich-Heine University, Duesseldorf

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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