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

Primary Purpose

Hypertrophic Cardiomyopathy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

additional temporary pacewire

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction, Biventricular Pacemaker cardiac surgery aortic valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years
Hypertrophic Cardiomyopathy
Aortic valve replacement

Exclusion Criteria:

Atrial fibrillation
Pericarditis
postoperative low output
Preoperative permanent pacemaker placement

Sites / Locations

Johann Wolfgang Goethe Universitätsklinikum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biventricular pacing

Arm Description

Outcomes

Primary Outcome Measures

Cardiac output

Secondary Outcome Measures

Full Information

NCT ID

NCT01081093

First Posted

March 4, 2010

Last Updated

August 5, 2014

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01081093

Brief Title

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Acronym

BIVENT

Official Title

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction, Biventricular Pacemaker cardiac surgery aortic valve replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biventricular pacing

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

additional temporary pacewire

Intervention Description

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

Primary Outcome Measure Information:

Title

Cardiac output

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years Hypertrophic Cardiomyopathy Aortic valve replacement Exclusion Criteria: Atrial fibrillation Pericarditis postoperative low output Preoperative permanent pacemaker placement

Facility Information:

Facility Name

Johann Wolfgang Goethe Universitätsklinikum

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

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