HIPACE High Frequency Low Energy Pacing to Terminate Fast... | NCT02629445

Studies
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias

NCT02629445

Sponsor

The Leeds Teaching Hospitals NHS Trust

Status

Completed

Last Update Posted

Feb 28, 2019Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Arrhythmias

Interventions

Cardiac Resynchronisation Defibrillator

Countries

United Kingdom

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

Feb 2019

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

Nov 2015Actual

Primary Completion Date

Jul 29, 2016Actual

Completion Date

Jul 29, 2016Actual

First Submitted Date

Dec 10, 2015

First Submission Date that Met QC Criteria

Dec 10, 2015

First Posted Date

Dec 14, 2015Estimated

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

Feb 26, 2019

Last Update Posted Date

Feb 28, 2019Actual

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

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.

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

8Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronisation Defibrillator	Device	Defibrillation testing of cardiac defibrilator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

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
Leeds Teaching Hospitals NHS Trust		Leeds	West Yorkshire	LS2 9LN	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided