Trial Outcomes & Findings for Spinal Stimulation During Exercise in Heart Failure (NCT NCT02659202)

Last Updated: 2024-05-22

Results Overview

This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

2 days

Results posted on

2024-05-22

Participant milestones
Measure	Precision Spinal Cord Stimulator System Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit. Precision Spinal Cord Stimulator System: The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Spinal Stimulation During Exercise in Heart Failure

Baseline characteristics by cohort
Measure	Precision Spinal Cord Stimulator System n=7 Participants Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit. Precision Spinal Cord Stimulator System: The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Age, Continuous	63.0 years STANDARD_DEVIATION 16.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

Timeframe: 2 days

This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.

Outcome measures
Measure	Precision Spinal Cord Stimulator System n=3 Participants Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit. Precision Spinal Cord Stimulator System: The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Mean Arterial Pressure	82.3 mmHg Standard Deviation 10.1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Precision Spinal Cord Stimulator System n=7 participants at risk Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit. Precision Spinal Cord Stimulator System: The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
General disorders Paresthesia	14.3% 1/7 • Number of events 1 • Adverse events were collected on each participant from enrollment through the end of the final visit, for approximately 1 month.

Mayo Clinic

Phone: 507-284-4375