Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement - Tabular View

Tracking Information

First Received Date ^ICMJE

March 4, 2010

Last Updated Date

August 26, 2011

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01081093 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Official Title ^ICMJE

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Brief Summary

Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.

A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.

The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Hypertrophic Cardiomyopathy

Intervention ^ICMJE

Procedure: additional temporary pacewire

Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy

Study Arms

Experimental: Biventricular pacing

Intervention: Procedure: additional temporary pacewire

Publications *

* 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

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years
Hypertrophic Cardiomyopathy
Aortic valve replacement

Exclusion Criteria:

Atrial fibrillation
Pericarditis
postoperative low output
Preoperative permanent pacemaker placement

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Arndt H Kiessling, MD

+49 (0) 69 / 6301 ext 0

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01081093

Other Study ID Numbers ^ICMJE

Bivent001AR-AHK

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

March 2010

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