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HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias (HIPACE)

Primary Purpose

Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiac Resynchronisation Defibrillator
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Arrhythmias

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent.

Exclusion Criteria:

  • Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing

Sites / Locations

  • Leeds Teaching Hospitals NHS Trust

Outcomes

Primary Outcome Measures

Rapid pacing of the heart
The primary outcome measure is to determine whether it is possible to obtain ventricular capture of the heart by repetitive pacing at very high rates during ventricular fibrillation.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2015
Last Updated
February 26, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02629445
Brief Title
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
Acronym
HIPACE
Official Title
High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 29, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronisation Defibrillator
Intervention Description
Defibrillation testing of cardiac defibrilator
Primary Outcome Measure Information:
Title
Rapid pacing of the heart
Description
The primary outcome measure is to determine whether it is possible to obtain ventricular capture of the heart by repetitive pacing at very high rates during ventricular fibrillation.
Time Frame
10 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent. Exclusion Criteria: Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9LN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias

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