NCT01081093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

4.3 years

First QC Date

March 4, 2010

Last Update Submit

August 5, 2014

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic Cardiomyopathy Diastolic Ventricular InteractionBiventricular Pacemaker cardiac surgery aortic valve replacement

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    intraoperative

Study Arms (1)

Biventricular pacing

EXPERIMENTAL
Procedure: additional temporary pacewire

Interventions

additional temporary pacewirePROCEDURE

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

Biventricular pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Hypertrophic Cardiomyopathy
  • Aortic valve replacement

You may not qualify if:

  • Atrial fibrillation
  • Pericarditis
  • postoperative low output
  • Preoperative permanent pacemaker placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe Universitätsklinikum

Frankfurt am Main, 60590, Germany

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

DE(1)