NCT01564173

Brief Summary

The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.8 years

First QC Date

March 24, 2012

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Invasive Dp/dt Max

    Variation on invasive Dp/dt max during dedicated pacing site

    Acute E.P. Procedure

Study Arms (1)

VT Ablation

Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach

You may qualify if:

  • Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
  • Be in sinus rhythm
  • Have LVEF \< 40%
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations

You may not qualify if:

  • Have permanent AF
  • Have pericardial disease
  • Have a recent myocardial infarction within 40 days prior to enrollment
  • Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
  • Have had a recent CVA or TIA within 3 months prior to enrollment
  • Be less than 18 years of age
  • Be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Bordeaux, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pierre Jais, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2012

First Posted

March 27, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

FR(1)