The primary objective is to assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bpm and:- an indication for…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the Inappropriate Shock Free Rate at 18 months compared
to a performance goal of 91.6%.
Secondary outcome
The secondary endpoints are:
- The All-Cause Shock Free Rate at 18 months compared to a performance goal of
85.8%
- System and Procedure Related Complications at 30 days compared to a
performance goal of 93.8%.
Background summary
Implantable cardioverter defibrillator (ICD) therapy is highly effective for
reducing mortality in patients with clinical markers for elevated risk for
ventricular arrhythmias. However, inappropriate shocks and unnecessary
appropriate shocks remain an important side effect that can significantly
affect an ICD recipient*s quality of life and may be deleterious to the
myocardium.
The MADIT RIT study demonstrated that the incidence of inappropriate and
unnecessary appropriate ICD therapy can be reduced in primary prevention
patients through two different programming strategies: 1) High Rate Zone
Cutoff, i.e., raising the lowest rate detection cutoff to 200 bpm and
initiating treatment after 2.5 seconds (tested in treatment Arm B), and; 2)
Delayed Therapy Initiation, i.e., increasing the time to therapy initiation to
60 seconds for arrhythmias detected between 170-199 bpm; 12.5 seconds between
200-249 bpm and 2.5 seconds above 250 bpm (tested in treatment Arm C). Both
strategies effectively reduced the amount of ICD therapy delivered when
compared to conventional programming (Arm A), where the lowest rate detection
cutoff was 170 bpm and the delay to therapy initiation was programmed to 2.5
seconds. Importantly, neither treatment arm was associated with significantly
increased syncope or mortality. The results of MADIT RIT firmly established
preferred device settings for transvenous ICD (TV-ICD) patients with a primary
prevention indication.
Preferred settings for subcutaneous ICDs, however, have not been established
with data from prospective studies. The UNTOUCHED study will test a programming
scheme designed to minimize inappropriate and unnecessary shocks in patients
who have an indication for primary prevention of sudden cardiac death and low
ejection fraction. Although S-ICD programming options do not permit exact
replication of the programmed settings previously shown to reduce shocks in
MADIT RIT Arms B and C, key elements of each programming scheme tested in MADIT
RIT are combined into the UNTOUCHED settings to be tested in this protocol.
Study objective
The primary objective is to assess the 18-month incidence of inappropriate
shocks in subjects implanted with the EMBLEM Subcutaneous Implantable
Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bpm and:
- an indication for implantation of a defibrillator for primary prevention of
sudden cardiac death;
- a left ventricular ejection fraction * 35%.
The 18-month incidence rate will be compared to an Objective Performance
Criteria derived from transvenous ICDs programmed to minimize shocks in the
MADIT RIT study.
The secondary objectives are to assess the 18-month incidence of all-cause
shocks and perioperative complications.
Device and procedure related complications at 6 months and implant success rate
at 3 months will be assessed to fulfill Post Market Clinical Follow-up (PMCF)
requirements.
Study design
The UNTOUCHED Study is a global, multi-site, prospective, non-randomized study
with a follow up of 18 months per subject.
Intervention
Patients are indicated and implanted with an subcutaneous ICD. There is no
further intervention.
Study burden and risks
The UNTOUCHED study has just one requirement beyond standard of care that may
entail incremental risk for study participants: programming of devices with a
conditional shock zone at 200 bpm and a shock zone at 250 bpm.
Potential adverse events related to the protocol include:
* Delayed therapy delivery
* Failure to deliver therapy
* Inappropriate shock delivery
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
- Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for a subcutaneous ICD (EMBLEM* S-ICD or newer generation BSC S-ICD)
- Left ventricular ejection fraction * 35%
- A passing EMBLEM* S-ICD (or newer generation BSC S-ICD) screening ECG
- Patient * 21 years of age willing and capable of giving informed consent
- Patient willing and capable of complying with follow-up visits
Exclusion criteria
- Patient with a history of spontaneous sustained VT or VF
- Patient with bradycardia pacing indication
- Patient eligible and scheduled for cardiac resynchronization implant
- Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator)
- Patient in NYHA Class IV documented in the medical records within 90 days before enrollment
- Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc*)
- Patient receiving hemodialysis within 180 days before to enrollment
- Patients unable to give consent in person, including patients unable to read or write
- Patient who is known to be pregnant or plans to become pregnant over the course of the trial
- Patient unwilling or unable to cooperate with the protocol
- Participation in concurrent clinical study without prior approval from Boston Scientific
- Medical status (e.g., hemodynamic conditions ) of the patient doesn*t allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53009.100.15 |