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NCT01081093 Clinical Trial

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Hypertrophic Cardiomyopathy Clinical Trial

— BIVENT  

Official title:
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01081093
Other study ID # Bivent001AR-AHK
Secondary ID
Status Completed
Phase N/A
First received March 4, 2010
Last updated August 5, 2014
Start date April 2010
Est. completion date August 2014

Study information
Verified date August 2014
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethikkommission Frankfurt am Main
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years

- Hypertrophic Cardiomyopathy

- Aortic valve replacement

Exclusion Criteria:

- Atrial fibrillation

- Pericarditis

- postoperative low output

- Preoperative permanent pacemaker placement

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Johann Wolfgang Goethe Universitätsklinikum Frankfurt am Main

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac output intraoperative Yes
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