Adenosine Testing to DEtermine the Need for Pacing Therapy (ADEPT-ILR)
|ClinicalTrials.gov Identifier: NCT01481168|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Syncope||Device: Pacemaker implantation (Medtronic) Device: Implantable Loop Recorder (Medtronic)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adenosine Testing to DEtermine the Need for Pacing Therapy With the Additional Use of an Implantable Loop Recorder (ADEPT-ILR Study). The Efficacy of Permanent Pacing in Patients With Syncope and a Positive Intravenous Adenosine Test: a Randomised, Double-blind, Placebo-controlled, Cross-over Trial.|
|Actual Study Start Date :||April 12, 2012|
|Actual Primary Completion Date :||January 26, 2017|
|Actual Study Completion Date :||January 26, 2017|
Active Comparator: Pacemaker "on"
Device: Pacemaker implantation (Medtronic)
Other Name: Medtronic DDD+/-R pacemakers
Placebo Comparator: Pacemaker "off"
Device: Pacemaker implantation (Medtronic)
Other Name: Medtronic DDR+/-R pacemakers.
Experimental: Implantable Loop Recorder
Implantable loop recorder in adenosine test negative patients
Device: Implantable Loop Recorder (Medtronic)
Loop recorder implantation
Other Name: Medtronic Reveal DX or XT
- Syncope Burden [ Time Frame: 12 months ]Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return
- Time to first syncope [ Time Frame: 12 months ]Time to first syncope
- Number of patients with recurrent syncope [ Time Frame: 12 months ]Number of patients with >1 episodes of syncope
- Quality of life [ Time Frame: 12 months ]Quality of life as measured via the condition-specific instrument the Impact of Syncope on Quality of Life questionnaire with general health-related quality of life measured via the WHOQoL-Brief and WHOQoL-Old instruments
- Health economic analysis [ Time Frame: 12 months ]Costs and benefits of the intervention to health and social services. (i) Use of EQ-5D questionnaire to establish the cost per Quality Adjusted Life Year (QALY) (ii) The analysis will include the patients described above as well as a historical comparator group of consecutive patients derived from the database held by the Falls and Syncope Service who have not undergone adenosine testing. This group is particularly important to establish the utility of adenosine testing in the diagnosis of unexplained syncope.
- ECG diagnosis on ILR following syncopal episode in adenosine negative group [ Time Frame: 12 months ]ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481168
|Royal Victoria Infirmary|
|Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP|
|Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN|
|Principal Investigator:||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|