Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement (BIVENT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01081093
First received: March 4, 2010
Last updated: August 5, 2014
Last verified: August 2014

March 4, 2010
August 5, 2014
April 2010
August 2014   (final data collection date for primary outcome measure)
Cardiac output [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01081093 on ClinicalTrials.gov Archive Site
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Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertrophic Cardiomyopathy
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
Experimental: Biventricular pacing
Intervention: Procedure: additional temporary pacewire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years
  • Hypertrophic Cardiomyopathy
  • Aortic valve replacement

Exclusion Criteria:

  • Atrial fibrillation
  • Pericarditis
  • postoperative low output
  • Preoperative permanent pacemaker placement
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01081093
Bivent001AR-AHK
No
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
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Johann Wolfgang Goethe University Hospitals
August 2014

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