Feasibility, safety and efficacy of Subcutaneous Electrical Nerve Stimulation (SENS) in patients with chronic refractory angina pectoris. A pilot study.

Feasibility, safety and efficacy of Subcutaneous Electrical Nerve Stimulation (SENS) in patients with chronic refractory angina pectoris. A pilot study. - SENS for refractory angina pectoris.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33732

Enrollment

Registered

2009-03-23

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

angina pectoris chest pain

Interventions

The SENS treatment incorporates subcutaneous implantation of 2 octopolar electrode-leads and an implantable pulse generator (IPG). Implantation will be performed under anesthesiological surveillance

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - stable angina pectoris, Canadian Cardiovascular Society (CCS) scale, class III-IV, therapeutic refractory for at least 3 months - anginal pain in the retrosternal and precordial area - angiographically documented coronary artery disease - demonstrated ischemia (by exercise test, 48h ECG registration, nuclide scan or PET) - optimal anti-anginal medication for >= 1 month - age >= 18 years

Exclusion criteria

Exclusion criteria: - Short life expectancy (i.e.

Design outcomes

Primary

Measure	Time frame
Since this is an explorative study, without any explicit hypotheses beforehand, we decided to make no formal distinction in primary and secondary endpoints. • Feasibility of the SENS implantation procedure - Technical: operation time, peri-operative complications, correct placement of the electrode-leads and IPG device - the ability to provoke paresthesias in the area of the chest pain • Safety All adverse events, including those expected to be unrelated to the SENS implantation will be recorded Related complications and anticipated and unanticipated adverse effects reported during this study will be evaluated. A list of expected complications is incorporated in the complication form (appendix 1) that will be completed by the implanting neurosurgeon. General risks associated with SENS implantation include: • Undesirable changes in stimulation over time • Hematoma or seroma of the wound • Lead migration • Infection • Pain at sites over the implanted system components • Mechanical failure Treatment complications will be reported by tabulation and classification according to their level of severity (mild/moderate/severe) and in their relation to the treatment (definite/probable/possible/not related). • Efficacy Data will be used to provide descriptive information about the outcomes mentioned below and to generate hypotheses about the efficacy of the SENS intervention. Efficacy evaluation will be done by measuring: Functional capacity Assessment is performed by making use of a standardized bicycle exercise tests (Naughton Protocol modified by Weber-Janicki). The exercise tests will be performed at baseline and at the end of the study period. The change in heart rate, rate pressure product, workload and ST-T segment and exercise capacity at the end of exercise will be scored as a percentage of the baseline. Frequency of anginal attacks A diary will be used by patients to self-report the number of angina episodes, angina episode intensi	—

Measure

Time frame

Since this is an explorative study, without any explicit hypotheses beforehand, we decided to make no formal distinction in primary and secondary endpoints. • Feasibility of the SENS implantation procedure - Technical: operation time, peri-operative complications, correct placement of the electrode-leads and IPG device - the ability to provoke paresthesias in the area of the chest pain • Safety All adverse events, including those expected to be unrelated to the SENS implantation will be recorded Related complications and anticipated and unanticipated adverse effects reported during this study will be evaluated. A list of expected complications is incorporated in the complication form (appendix 1) that will be completed by the implanting neurosurgeon. General risks associated with SENS implantation include: • Undesirable changes in stimulation over time • Hematoma or seroma of the wound • Lead migration • Infection • Pain at sites over the implanted system components • Mechanical failure Treatment complications will be reported by tabulation and classification according to their level of severity (mild/moderate/severe) and in their relation to the treatment (definite/probable/possible/not related). • Efficacy Data will be used to provide descriptive information about the outcomes mentioned below and to generate hypotheses about the efficacy of the SENS intervention. Efficacy evaluation will be done by measuring: Functional capacity Assessment is performed by making use of a standardized bicycle exercise tests (Naughton Protocol modified by Weber-Janicki). The exercise tests will be performed at baseline and at the end of the study period. The change in heart rate, rate pressure product, workload and ST-T segment and exercise capacity at the end of exercise will be scored as a percentage of the baseline. Frequency of anginal attacks A diary will be used by patients to self-report the number of angina episodes, angina episode intensi

—

Secondary

Measure	Time frame
Zie primary study parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)