NCT01481168

Adenosine Testing to DEtermine the Need for Pacing Therapy

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Syncope

Interventions

Type	Name	Description
DEVICE	Pacemaker implantation (Medtronic)	DDD+/-R pacing
DEVICE	Pacemaker implantation (Medtronic)	ODO pacing
DEVICE	Implantable Loop Recorder (Medtronic)	Loop recorder implantation

Timeline

• Start date: 2012-04-12
• Primary completion: 2017-01-26
• Completion: 2017-01-26
• First posted: 2011-11-29
• Last updated: 2017-11-20

Locations

2 sites across 1 country: United Kingdom