Biventricular Pacing in Hypertrophic Cardiomyopathy After... | NCT01081093

Studies
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

NCT01081093

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Aug 6, 2014Estimated

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Hypertrophic Cardiomyopathy

Interventions

additional temporary pacewire

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2014

Last Update Posted Date

Aug 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biventricular pacing	Experimental		Procedure: additional temporary pacewire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
additional temporary pacewire	Procedure	Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy

Measure	Description	Time Frame
Cardiac output		intraoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years
Hypertrophic Cardiomyopathy
Aortic valve replacement

Exclusion Criteria:

Atrial fibrillation
Pericarditis
postoperative low output
Preoperative permanent pacemaker placement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johann Wolfgang Goethe Universitätsklinikum		Frankfurt am Main		60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular

Browse Leaves

Not provided

Browse Branches

Not provided