Trial Outcomes & Findings for REmodeling the Left Ventricle With Atrial Modulated Pacing (NCT NCT03210402)

Last Updated: 2024-10-08

Results Overview

REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline through 12 week follow-up

Results posted on

2024-10-08

Participant Flow

All eligible subjects were approached for participation during the entire recruitment period (site activation through enrollment closure) at each participating site.

After completing a baseline visit but before randomization, all subjects received four weeks of elevated night pacing. 8 subjects exited the study before randomization, and are not shown as exits in the study period table. Of these 8 subject exits, 3 exited after enrollment due to screening failures, and 5 exited between the baseline visit and randomization due to withdrawal by subject.

Participant milestones

Participant milestones
Measure	Pacing On Elevated night pacing on: Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times for 4 weeks, then therapy will be discontinued	Pacing Off Patient will receive no pacing therapy
Overall Study STARTED	9	5
Overall Study COMPLETED	9	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pacing On Elevated night pacing on: Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times for 4 weeks, then therapy will be discontinued	Pacing Off Patient will receive no pacing therapy
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Sex not collected for the 3 subjects who failed screening.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Patients n=22 Participants All enrolled patients
Age, Continuous	77.3 Years STANDARD_DEVIATION 8.4 • n=22 Participants
Sex: Female, Male Female	8 Participants n=19 Participants • Sex not collected for the 3 subjects who failed screening.
Sex: Female, Male Male	11 Participants n=19 Participants • Sex not collected for the 3 subjects who failed screening.
Region of Enrollment United States	22 participants n=22 Participants
NYHA Class Classification not available	4 Participants n=22 Participants
NYHA Class Subject Does Not have Heart Failure	1 Participants n=22 Participants
NYHA Class Class 1)No symptoms and no limitation in ordinary physical activity	0 Participants n=22 Participants
NYHA Class Class 2) Slight limitation of physical activity.	9 Participants n=22 Participants
NYHA Class Class 3) Marked limitation of physical activity.	8 Participants n=22 Participants
NYHA Class Class 4) Unable to carry on any physical activity without discomfort. Symptoms at rest.	0 Participants n=22 Participants

PRIMARY outcome

Timeframe: Baseline through 12 week follow-up

Population: Subjects were randomized to these two arms after an initial 4-week baseline period in which all subjects had their device programmed to provide elevated night pacing.

Outcome measures

Outcome measures
Measure	Elevated Night Pacing on n=9 Participants Elevated night pacing on: Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times	Elevated Night Pacing Off n=5 Participants Elevated night pacing off: Device will be programmed to normal lower rates
Number of Participants Who Remained on Study	9 participants	4 participants

Adverse Events

Elevated Night Pacing On Before Randomization

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Elevated Night Pacing On From Randomization To 8 Weeks

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Elevated Night Pacing Off From Randomization To 8 Weeks

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Elevated Night Pacing Off After 8 Weeks

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Elevated Night Pacing On Before Randomization n=22 participants at risk This arm includes all subjects as assessed from study start until randomization at the 4-week visit. Note that all subjects received elevated night pacing during this period.	Elevated Night Pacing On From Randomization To 8 Weeks n=9 participants at risk This arm includes subjects that were randomized to continue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit.	Elevated Night Pacing Off From Randomization To 8 Weeks n=5 participants at risk This arm includes subjects that were randomized to discontinue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit.	Elevated Night Pacing Off After 8 Weeks n=13 participants at risk This arm includes all subjects as assessed from the 8-week visit until study exit. Note that no subjects received elevated night pacing during this period.
Cardiac disorders Atrial fibrillation	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Cardiac disorders Cardiac failure	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Cardiac disorders Cardiac failure chronic	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
General disorders Chest pain	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Hepatobiliary disorders Cholecystitis	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Ankle fracture	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Renal and urinary disorders Acute kidney injury	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Renal and urinary disorders Nephrolithiasis	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	11.1% 1/9 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Vascular disorders Embolism	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	Elevated Night Pacing On Before Randomization n=22 participants at risk This arm includes all subjects as assessed from study start until randomization at the 4-week visit. Note that all subjects received elevated night pacing during this period.	Elevated Night Pacing On From Randomization To 8 Weeks n=9 participants at risk This arm includes subjects that were randomized to continue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit.	Elevated Night Pacing Off From Randomization To 8 Weeks n=5 participants at risk This arm includes subjects that were randomized to discontinue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit.	Elevated Night Pacing Off After 8 Weeks n=13 participants at risk This arm includes all subjects as assessed from the 8-week visit until study exit. Note that no subjects received elevated night pacing during this period.
Cardiac disorders Cardiac failure	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Cardiac disorders Cardiac failure congestive	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	11.1% 1/9 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	7.7% 1/13 • Number of events 2 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
General disorders Chest pain	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
General disorders Device intolerance	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
General disorders Fatigue	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Investigations Heart rate increased	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/22 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	7.7% 1/13 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Nervous system disorders Presyncope	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Psychiatric disorders Insomnia	9.1% 2/22 • Number of events 2 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.
Vascular disorders Hypotension	4.5% 1/22 • Number of events 1 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/9 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.	0.00% 0/13 • Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early. Definitions are consistent with clinicaltrials.gov definitions.

Additional Information

Mike Bennett, Clinical Study Manger

Medtronic Inc

Phone: 262-362-1956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Participating Institution and Principal Investigator may publish the results of work performed under this Agreement, in accordance with the publication strategy described in the Protocol; provided, however, that any such Publication will be provided to Medtronic for review at least forty five (45) days prior to submission or presentation; provided, however, that such publication strategy in no way shall prevent Institution from freely utilizing data for Publication
Publication restrictions are in place

Restriction type: OTHER