Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01801098
First received: February 6, 2013
Last updated: November 12, 2013
Last verified: November 2013

February 6, 2013
November 12, 2013
December 2012
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01801098 on ClinicalTrials.gov Archive Site
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 ]
Same as current
cardiovascular mortality [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
Same as current
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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

Symptomatic Aortic Valve Stenosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • unconsciousness, not able to consent
  • < 18 years
  • permanent pacemaker
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01801098
HV-interval prior TAVI
No
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Klinik für Kardiologie, Pneumologie und Angiologie
Not Provided
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
Heinrich-Heine University, Duesseldorf
November 2013

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