Adenosine Testing to DEtermine the Need for Pacing Therapy (ADEPT-ILR)

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Completed

Conditions: Syncope

Treatments: Device: Pacemaker implantation (Medtronic); Device: Implantable Loop Recorder (Medtronic)

Study type: Interventional

Funder types: Other

Identifiers

NCT01481168

5883

FS/11/13/28690 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

Pacemaker "on"

Active Comparator group

Description:

DDD+/-R pacing

Treatment:

Device: Pacemaker implantation (Medtronic)

Device: Pacemaker implantation (Medtronic)

Pacemaker "off"

Placebo Comparator group

Description:

ODO pacing

Treatment:

Device: Pacemaker implantation (Medtronic)

Device: Pacemaker implantation (Medtronic)

Implantable Loop Recorder

Experimental group

Description:

Implantable loop recorder in adenosine test negative patients

Treatment:

Device: Implantable Loop Recorder (Medtronic)