Trial Outcomes & Findings for Extravascular ICD Pilot Study (NCT NCT03608670)
NCT ID: NCT03608670
Last Updated: 2024-01-08
Results Overview
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 5 such episodes may be induced to test device efficacy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
At Implantation
Results posted on
2024-01-08
Participant Flow
26 participants consented and enrolled into the protocol. 5 participants were exited prior to an implant attempt.
Participant milestones
| Measure |
Experimental
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Implant Attempted
|
21
|
|
Overall Study
Successfully Implanted
|
17
|
|
Overall Study
2-week Follow-up
|
17
|
|
Overall Study
4-6 Weeks Follow-up
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extravascular ICD Pilot Study
Baseline characteristics by cohort
| Measure |
Experimental
n=26 Participants
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Maori
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Macedonian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: Afghani
|
1 Participants
n=5 Participants
|
|
ICD Indication
Class I indication: Cardiac arrest due to VF/hemodynamically unstable sustained VT
|
4 Participants
n=5 Participants
|
|
ICD Indication
Class I indication: Structural heart disease and spontaneous sustained VT
|
1 Participants
n=5 Participants
|
|
ICD Indication
Class I indication: LVEF ≤ 35% due to prior MI, NYHA Class II or III
|
5 Participants
n=5 Participants
|
|
ICD Indication
Class I indication: Nonischemic dilated cardiomyopathy, LVEF ≤ 35%, NYHA Class II or III
|
5 Participants
n=5 Participants
|
|
ICD Indication
Class IIa indication: LV dysfunction due to prior MI, LVEF ≤ 30%, NYHA Class I
|
3 Participants
n=5 Participants
|
|
ICD Indication
Class I Indication: Hypertrophic cardiomyopathy, 1 or more major risk factors for SCD
|
6 Participants
n=5 Participants
|
|
ICD Indication
Class I Indication: Arrhythmogenic RV dysplasia / cardiomyopathy, ≥ 1 risk factor for SCD
|
1 Participants
n=5 Participants
|
|
ICD Indication
Class IIb indication: Nonischemic heart disease, LVEF ≤ 35%, NYHA functional Class I
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At ImplantationPopulation: Number of participants who underwent and completed the defibrillation testing protocol.
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 5 such episodes may be induced to test device efficacy.
Outcome measures
| Measure |
Experimental
n=20 Participants
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
|
18 Participants
|
PRIMARY outcome
Timeframe: 3 months (90 days)Population: All participants for whom an implant of the investigational product was attempted were included in the analysis
Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant.
Outcome measures
| Measure |
Experimental
n=21 Participants
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)
|
94.1 percentage of participants
Interval 83.6 to 100.0
|
Adverse Events
Experimental
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=21 participants at risk
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Product Issues
Lead dislodgement
|
9.5%
2/21 • Number of events 2 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Vascular disorders
Orthostatic hypotension
|
4.8%
1/21 • Number of events 2 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Renal and urinary disorders
Urinary retention
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Nervous system disorders
Migraine
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
Other adverse events
| Measure |
Experimental
n=21 participants at risk
Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing.
Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
9.5%
2/21 • Number of events 2 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Cardiac disorders
Ventricular tachycardia
|
4.8%
1/21 • Number of events 2 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 2 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Nervous system disorders
Lethargy
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
General disorders
Implant site swelling
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
General disorders
Impaired healing
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Infections and infestations
Postoperative wound infection
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Cardiac disorders
Atrial tachycardia
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
General disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • Assessed from Implant visit through to 3 Months (90 days inclusive)
|
Additional Information
CRM Clinical Research
Medtronic Cardiac Rhythm Management
Phone: +1 800 328 2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place