Extravascular ICD Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 26
- Locations
- 4
- Primary Endpoint
- Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
Detailed Description
The study will recruit male and female adult subjects that meet all of the inclusion criteria and none of the exclusion criteria. All subjects will be indicated to receive an ICD. The EV ICD system will be implanted and the subjects will be followed for at least 3 months following implantation of the system. Subjects will be exited after follow-up is completed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines\[1\]
- •Patient is willing and able to sign and date the Informed Consent Form.
- •Patient is at least 18 years of age and meets age requirements per local law
- •Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up
- •\[1\] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias
Exclusion Criteria
- •Patient has indications for bradycardia pacing \[1\] or Cardiac Resynchronization Therapy (CRT) \[2\] (Class I, IIa, or IIb indication)
- •Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
- •Patient has anatomical abnormality that significantly increases implant risk\[3\] including:
- •Severe obesity \[4\]
- •Marked RV dilation
- •Marked sternal abnormality
- •Hiatus hernia that distorts mediastinal anatomy
- •Patient has prior chest radiotherapy
- •Patient had previous mediastinitis
- •Patient had previous coronary artery bypass grafting procedure
Outcomes
Primary Outcomes
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
Time Frame: At Implantation
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.
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)
Time Frame: 3 months (90 days)
Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant.