Benefit of dual-chamber pacing with Closed Loop Stimulation (CLS) in tilt-induced cardio-inhibitory reflex syncope. A randomized double-blind parallel trial.

Benefit of dual-chamber pacing with Closed Loop Stimulation (CLS) in tilt-induced cardio-inhibitory reflex syncope. A randomized double-blind parallel trial. - BIOSync CLS study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42000

Enrollment

Registered

2015-08-13

Start date

2016-11-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio-inhibitorisch reflex syncope Tilt-Induced cardio-inhibitory reflex syncope

Interventions

Tilt-test

Vasovagal

Patients will be randomized to the active or to the placebo group immediately after their enrolment and before any subsequent study-related procedure. Both patient groups will implanted with a Biotro

Syncope

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: *Age >40 years. *significant limitation of social and working life due to unpredictable or frequent syncope recurrences: *2 within the last year. *type 2B cardio-inhibitory response to TTT (according to the VASIS classification). *alternative therapies have failed or are not feasible. *exclusion of other possible competitive causes of syncope.

Exclusion criteria

Exclusion criteria: *Any other indication to IPG (pacemaker), implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines. *Any cardiac dysfunctions possibly leading to loss of consciousness: overt heart failure; ejection fraction (LVEF)

Design outcomes

Primary

Measure	Time frame
Syncope	—

Secondary

Measure	Time frame
Pre-syncope	—

Countries

France, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)