NCT01481168

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

April 12, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

November 22, 2011

Last Update Submit

November 17, 2017

Conditions

Syncope

Outcome Measures

Primary Outcomes (1)

  • Syncope Burden

    Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return

    12 months

Secondary Outcomes (5)

  • Time to first syncope

    12 months

  • Number of patients with recurrent syncope

    12 months

  • Quality of life

    12 months

  • Health economic analysis

    12 months

  • ECG diagnosis on ILR following syncopal episode in adenosine negative group

    12 months

Study Arms (3)

Pacemaker "on"

ACTIVE COMPARATOR

DDD+/-R pacing

Device: Pacemaker implantation (Medtronic)

Pacemaker "off"

PLACEBO COMPARATOR

ODO pacing

Device: Pacemaker implantation (Medtronic)

Implantable Loop Recorder

EXPERIMENTAL

Implantable loop recorder in adenosine test negative patients

Device: Implantable Loop Recorder (Medtronic)

Interventions

Pacemaker implantation (Medtronic)DEVICE

DDD+/-R pacing

Also known as: Medtronic DDD+/-R pacemakers
Pacemaker "on"
Implantable Loop Recorder (Medtronic)DEVICE

Loop recorder implantation

Also known as: Medtronic Reveal DX or XT
Implantable Loop Recorder

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Feeeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steve W Parry, PhD, MBBS, MRCP, BSc

    Institue of Ageing and Health, University of Newcastle

    PRINCIPAL INVESTIGATOR

  • Chris J Pummer, PhD, MRCP, BMBCh, BSc

    Newcastle upon Tyne Hospitals NHS FOundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 29, 2011

Study Start

April 12, 2012

Primary Completion

January 26, 2017

Study Completion

January 26, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

GB(2)