PatientsVille.com LogoPatientsVille.com

Syncope | Adenosine Testing to DEtermine the Need for Pacing Therapy

Syncope research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Pacemaker implantation (Medtronic)DDD+/-R pacing

Device:Pacemaker implantation (Medtronic)ODO pacing

Device:Implantable Loop Recorder (Medtronic)Loop recorder implantation

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pacemaker "on"DDD+/-R pacing

Pacemaker "off"ODO pacing

Implantable Loop RecorderImplantable loop recorder in adenosine test negative patients

Study Status

Completed

Start Date: April 12, 2012

Completed Date: January 26, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Syncope Burden

Secondary Outcome: Time to first syncope

Study sponsors, principal investigator, and references

Principal Investigator: Steve W Parry, PhD, MBBS, MRCP, BSc

Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01481168

Discuss Syncope