NCT02629445

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 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

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2016

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

December 10, 2015

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 seconds

Interventions

Defibrillation testing of cardiac defibrilator

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS2 9LN, United Kingdom

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 14, 2015

Study Start

November 1, 2015

Primary Completion

July 29, 2016

Study Completion

July 29, 2016

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations