Trial Outcomes & Findings for Chronic Evaluation of Respicardia Therapy (NCT NCT01124370)
NCT ID: NCT01124370
Last Updated: 2016-05-16
Results Overview
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline and 3 months on therapy
Results posted on
2016-05-16
Participant Flow
Participant milestones
| Measure |
Treatment
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
Successfully Implanted
|
50
|
|
Overall Study
Therapy Initiated
|
48
|
|
Overall Study
3 Month Visit
|
47
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Evaluation of Respicardia Therapy
Baseline characteristics by cohort
| Measure |
Treatment
n=57 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
|
Apnea-Hypopnea Index (AHI)
|
49.1 events/hour
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
8.6 units on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Minnesota Living with Heart Failure Questionnaire (MNLHF)
|
41.4 units on a scale
STANDARD_DEVIATION 18.9 • n=5 Participants
|
|
Six minute hall walk
|
377.8 meters
STANDARD_DEVIATION 144.5 • n=5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Not applicable
|
11 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class I
|
4 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class II
|
28 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class III
|
13 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class IV
|
1 participants
n=5 Participants
|
|
Heart failure
Yes
|
46 participants
n=5 Participants
|
|
Heart failure
No
|
11 participants
n=5 Participants
|
|
Ejection Fraction
|
29.6 percent
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Coronary Artery Disease
Yes
|
35 participants
n=5 Participants
|
|
Coronary Artery Disease
No
|
22 participants
n=5 Participants
|
|
Hypertension
Yes
|
41 participants
n=5 Participants
|
|
Hypertension
No
|
16 participants
n=5 Participants
|
|
Hyperlipidemia
Yes
|
20 participants
n=5 Participants
|
|
Hyperlipidemia
No
|
37 participants
n=5 Participants
|
|
Atrial Fibrillation
Yes
|
16 participants
n=5 Participants
|
|
Atrial Fibrillation
No
|
41 participants
n=5 Participants
|
|
Concomitant implantable device delivering therapy
Yes
|
29 participants
n=5 Participants
|
|
Concomitant implantable device delivering therapy
No
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months on therapyPopulation: The evaluable population includes subjects who completed a 3 Month post therapy initiation visit.
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
Outcome measures
| Measure |
Treatment
n=47 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
AHI Change From Baseline at 3 Months
|
-27.1 events/hour
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Subjects with an implant attempt.
The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.
Outcome measures
| Measure |
Treatment
n=57 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Related Adverse Events
Serious
|
18 participants
|
|
Related Adverse Events
Non-Serious
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 months on therapyPopulation: Subjects with baseline and 6 month data.
Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.
Outcome measures
| Measure |
Treatment
n=46 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Epworth Sleepiness Scale Change From Baseline at 6 Months
|
-2.0 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline and 6 months on therapyPopulation: Heart failure subjects with baseline and 6 month results.
Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.
Outcome measures
| Measure |
Treatment
n=36 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
|
-9.9 units on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: 6 months on therapyPopulation: Evaluable subjects with heart failure at baseline.
The composite is determined according to the following definitions. Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF. Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward. Unchanged: patient was neither improved nor worsened.
Outcome measures
| Measure |
Treatment
n=37 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Heart Failure Clinical Composite
Improved
|
20 participants
|
|
Heart Failure Clinical Composite
Unchanged
|
9 participants
|
|
Heart Failure Clinical Composite
Worsened
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 months on therapyPopulation: Subjects with baseline and 6 month data.
Change = Month 6 score - Baseline score
Outcome measures
| Measure |
Treatment
n=39 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Six-minute Hall Walk Test Change From Baseline at 6 Months
|
-7.5 meters
Standard Deviation 58.7
|
SECONDARY outcome
Timeframe: Baseline and 6 months on therapyPopulation: Heart failure subjects with 6 month data.
Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases.
Outcome measures
| Measure |
Treatment
n=36 Participants
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
NYHA Functional Class Improvement From Baseline to 6 Months
Improved
|
11 participants
|
|
NYHA Functional Class Improvement From Baseline to 6 Months
No change
|
25 participants
|
|
NYHA Functional Class Improvement From Baseline to 6 Months
Worsened
|
0 participants
|
Adverse Events
Treatment
Serious events: 41 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=57 participants at risk
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
ATYPICAL CHEST PAIN
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Musculoskeletal and connective tissue disorders
GOUT ATTACK
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Musculoskeletal and connective tissue disorders
SPINAL CANAL STENOSIS
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Nervous system disorders
EPILEPTIC SEIZURE
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Nervous system disorders
HEADACHE
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Nervous system disorders
MENINGIOMA
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Psychiatric disorders
DELUSIONAL SYNDROME
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Renal and urinary disorders
RENAL DYSFUNCTION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Respiratory, thoracic and mediastinal disorders
COPD EXACERBATION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONITIS
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD LESION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Skin and subcutaneous tissue disorders
ATOPIC ECZEMA
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Surgical and medical procedures
CRT-D DEVICE REPLACEMENT
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
ACUTE CONGESTIVE HEART FAILURE
|
24.6%
14/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
LEAD DISLODGEMENT
|
19.3%
11/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
10.5%
6/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
ATRIAL ARRHYTHMIA
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
CHEST PAIN
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Gastrointestinal disorders
CLOSTRIDIAL ENTERITIS
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
EXTRA-RESPIRATORY STIMULATION
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
LEAD COMPONENT FAILURE
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Infections and infestations
BRONCHITIS
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Infections and infestations
PNEUMONIA
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Nervous system disorders
STROKE
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
THROMBOSIS
|
3.5%
2/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
AV BLOCK
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Eye disorders
DETACHED RETINA
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Eye disorders
WORSENING OF CATARACTS
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Gastrointestinal disorders
GI BLEEDING
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
HERNIA REPAIR
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
IMPENDING POCKET PERFORATION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
INADEQUATE LEAD POSITION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
LOSS OF STIMULATION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Metabolism and nutrition disorders
DIABETES
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Metabolism and nutrition disorders
HYPEROSMOLAR SYNDROME
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Surgical and medical procedures
DEVICE EXPLANTATION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
HEMATOMA
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
HYPOTENSION
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
PERIPHERAL VASCULAR DISEASE
|
1.8%
1/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
Other adverse events
| Measure |
Treatment
n=57 participants at risk
Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
|
|---|---|
|
General disorders
DIAPHRAGMATIC STIMULATION DISCOMFORT
|
28.1%
16/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
10.5%
6/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Cardiac disorders
ACUTE CONGESTIVE HEART FAILURE
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
EXTRA-RESPIRATORY STIMULATION
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
General disorders
PAIN
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
HEMATOMA
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
|
Vascular disorders
HYPOTENSION
|
5.3%
3/57 • 2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place