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Cardiac pacing for the prevention of falls in carotid sinus hypersensitivity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98608799
Enrollment
20
Registered
2002-01-31
Start date
1998-10-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Carotid sinus syndrome Nervous System Diseases Carotid sinus syndrome

Interventions

Cardiac pacemaker versus Thera rate drop responsive Medtronic Inc dual chamber pacemaker.

Sponsors

British Heart Foundation (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Added 16/02/2009: 1. Aged greater than or equal to 50 years, either sex 2. A minimum of two unexplained falls, +/- up to one syncope, in the previous 12 months 3. Mini Mental State Examination (MMSE) greater than 20/30 4. Sinus rhythm 5. Greater than 3 s asystole (upright or supine) during carotid sinus massage (CSM) (i.e. cardio-inhibitory carotid sinus hypersensitivity) 6. Gait, balance, and vision, as assessed by attending physician, not attributable cause of falls Initial information at time of registration: Patients with a history of unexplained falls with reproducible cardio-inhibitory or mixed carotid sinus hypersensitivity

Exclusion criteria

Exclusion criteria: Added 16/02/2009: 1. Contraindication to CSM 2. Atrial fibrillation 3. Medications which enhance vagal activity 4. Neoplasm 5. Chronic renal failure 6. Chronic liver disease 7. Heart failure (New York Heart Association [NYHA] class III/IV)

Design outcomes

Primary

MeasureTime frame
Added 16/02/2009: Number of patients who fall in the 24 months following intervention.

Secondary

MeasureTime frame
Added 16/02/2009: 1. Frequency of falls 2. Dizzy symptoms and presyncope 3. Perceived health and mental status including informant?s perception and patient?s perception 4. Injury rates 5. Use of primary, secondary and tertiary care facilities 6. Length of hospital admission 7. Change in residential circumstances 8. Cognitive function

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026