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Adenosine Testing to DEtermine the Need for Pacing Therapy

NCT ID: NCT01481168

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-12

Study Completion Date

2017-01-26

Brief Summary

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The purpose of this study is to determine whether or not the intravenous adenosine test readily identifies patients with unexplained syncope who would benefit from permanent pacemaker implantation.

Detailed Description

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The investigation of syncope (transient loss of consciousness with loss of postural tone, collapse and spontaneous recovery) varies widely, is often lengthy and frequently expensive. The intravenous adenosine test has been used in the investigation of syncope and is cheap, safe and free of serious side effects. However, it is unclear what diagnosis the test unearths. There is some evidence that the test readily identifies bradycardia pacing indications.

In this study we plan to perform the adenosine test and implant a pacemaker should the test be positive. In half of the patients we will turn the pacemaker "on" and in the other half the pacemaker "off". The groups will swap over after six months. During this time we will assess the number of syncopal episodes. Also, in those who have a negative adenosine test we will implant a loop recorder to try to discover the cause of syncope.

Conditions

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Syncope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pacemaker "on"

DDD+/-R pacing

Group Type ACTIVE_COMPARATOR

Pacemaker implantation (Medtronic)

Intervention Type DEVICE

DDD+/-R pacing

Pacemaker "off"

ODO pacing

Group Type PLACEBO_COMPARATOR

Pacemaker implantation (Medtronic)

Intervention Type DEVICE

ODO pacing

Implantable Loop Recorder

Implantable loop recorder in adenosine test negative patients

Group Type EXPERIMENTAL

Implantable Loop Recorder (Medtronic)

Intervention Type DEVICE

Loop recorder implantation

Interventions

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Pacemaker implantation (Medtronic)

DDD+/-R pacing

Intervention Type DEVICE

Pacemaker implantation (Medtronic)

ODO pacing

Intervention Type DEVICE

Implantable Loop Recorder (Medtronic)

Loop recorder implantation

Intervention Type DEVICE

Other Intervention Names

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Medtronic DDD+/-R pacemakers Medtronic DDR+/-R pacemakers. Medtronic Reveal DX or XT

Eligibility Criteria

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Inclusion Criteria

* Episode of syncope
* Patient has provided written informed consent for participation in the study prior to any study specific procedures
* Male or female
* Age \> 40 years
* No cause of syncope clearly identified on clinical examination, lying and standing blood pressure measurements and standard 12 lead ECG.

Exclusion Criteria

* Asthma or chronic obstructive pulmonary disease
* Severe coronary disease (myocardial infarction within 3 months, known coronary stenosis \>70%, NYHA heart failure or angina symptoms Class III or IV)
* Known severe cerebrovascular disease or known significant internal carotid artery stenosis (\>70%)
* Prolonged corrected QT interval
* Unablated accessory pathway
* Pregnancy or lactation
* Use of dipyridamole or any rate-limiting medication that cannot be safely discontinued
* Hypertrophic cardiomyopathy
* Cardiac transplantation
* Concurrent participation in another investigational study or trial
* Inability to give informed consent; carer/proxy assent will be allowed in this study
* Cause of syncope established from initial clinical history and examination, lying and standing blood pressure and ECG
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve W Parry, PhD, MBBS, MRCP, BSc

Role: PRINCIPAL_INVESTIGATOR

Institue of Ageing and Health, University of Newcastle

Chris J Pummer, PhD, MRCP, BMBCh, BSc

Role: PRINCIPAL_INVESTIGATOR

Newcastle upon Tyne Hospitals NHS FOundation Trust

Locations

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Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Feeeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FS/11/13/28690

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5883

Identifier Type: -

Identifier Source: org_study_id