ISSUE3: International Study on Syncope of Uncertain Etiology 3

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Guideline-based Pacing Therapy for Reflex Syncope

NCT01509534

Syncope

COMPLETED

Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

NCT04229589

Syncope

UNKNOWN

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

NCT01463358

Bifascicular Block Syncope

COMPLETED NA

Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.

NCT05896592

Bradycardia Syncope

RECRUITING NA

Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

NCT05855603

Reflex Syncope

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33% rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover, the control non-asystolic group still continued to have a 41% recurrence rate after the first recurrence of syncope, thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors. However a formal controlled trial is needed to confirm these findings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syncope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dual chamber pacemaker

Dual chamber pacemaker programmed ODO (switched OFF)

Group Type PLACEBO_COMPARATOR

Dual chamber pacemeker

Intervention Type DEVICE

Dual chamber pacemeker

Medtronic dual chamber pacemaker programmed ON and with Rate Drope Response programmed ON

Group Type ACTIVE_COMPARATOR

Dual chamber pacemeker

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual chamber pacemeker

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Any model of Medtronic pacemakers with Rate Drop Respons algorhythm: K700, K900, Enpulse, Advisa, Versa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suspected or certain neurally-mediated syncope, based on the Guidelines recently published by the Task Force on Syncope of the European Society of Cardiology 2,3 (Appendix 1);
* More than 3 syncope episodes in the last 2 years;
* Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician's and patient's judgement.
* Age \> 40 years.
* Negative carotid sinus massage.
* Patients accept to have an ILR implantation.

Exclusion Criteria

* Carotid sinus hypersensitivity
* Suspected or certain heart disease and high likelihood of cardiac syncope:
* Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;
* Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy);
* Subclavian steal syndrome;
* Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
* Patient compliance doubtful;
* Patient geographically or otherwise inaccessible for follow-up;
* Patient unwilling or unable to give informed consent;
* Life expectancy \<1 year.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No