An interventional study of Protecta VR-ICD and Protecta DR-ICD or CRT-D in Tachyarrhythmias, Heart Failure and Ventricular Dysfunction, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 122 sites in 21 countries. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Treatment
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.
The PainFree SST study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. Phase I assessed safety as determined by assessment of delays in ventricular fibrillation (VF) arrhythmia detection time using new algorithms. Phase II assessed the influence of new algorithms on inappropriate and unnecessary shocks at 1 year of follow-up. Subjects enrolled in Phase I continued in Phase II of the study and data from all enrolled subjects contributed to the analysis of Phase II objectives. A sub-study of Phase II randomized secondary prevention subjects to either 18/24 NID or 30/40 NID in order to assess the safety of prolonged detection in these patients.
262 studies on the registry are indexed under Ventricular Dysfunction; 40 are open to participants now.
This study's enrollment of 2,770 is above the median of 63 across 144 interventional studies indexed under Ventricular Dysfunction.
Browse Ventricular Dysfunction studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients meeting one of the following criteria can be included in Phase I of the study:
Patients meeting one of the following criteria can be included in Phase II of the study:
Exclusion Criteria:
Patients implanted with a Protecta VR-ICD.
Device: Protecta VR-ICD
Patients implanted with a Protecta DR-ICD or CRT-D.
Device: Protecta DR-ICD or CRT-D
Protecta single-chamber implantable cardioverter defibrillators.
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Percentage of Subjects Who Are Inappropriate Shock Free
Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
Time frame: Implant to one year post-implant
Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Time frame: Implant to one month post-implant
Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
Time frame: At implant
Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free
Time frame: Implant to one year post-implant
| Milestone | DR-ICD/CRT-D | VR-ICD |
|---|---|---|
| Started | 236 | 0 |
| Completed | 236 | 0 |
| Not completed | 0 | 0 |
| Milestone | DR-ICD/CRT-D | VR-ICD |
|---|---|---|
| Started | 2019 | 751 |
| Secondary prevention randomized 18/24nid | 231 | 122 |
| Secondary prevention randomized 30/40nid | 221 | 131 |
| Completed | 2019 | 751 |
| Not completed | 0 | 0 |
Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
| percentage of patients | DR-ICD/CRT-D | VR-ICD |
|---|---|---|
| Percentage of Subjects Who Are Inappropriate Shock Free | 98.5 (97.9 to 99.0) | 97.5 (96.1 to 98.5) |
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
| percentage of patients | Phase I |
|---|---|
| Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) | 0 (NA to 3.0) |
In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
| percentage of patients | Phase I |
|---|---|
| Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off | 100 (98.1 to NA) |
| percentage of patients | 18/24 NID | 30/40 NID |
|---|---|---|
| Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free | 96 | 96 |
Collected over Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DR-ICD/CRT-D | — | 452/2,019 (22.4%) | — |
| VR-ICD | — | 125/751 (16.6%) | — |
| Event | DR-ICD/CRT-D | VR-ICD |
|---|---|---|
| Cardiac failureCardiac disorders | 108/2019 | 29/751 |
| Ventricular tachycardiaCardiac disorders | 40/2019 | 14/751 |
| Atrial fibrillationCardiac disorders | 33/2019 | 4/751 |
| Device dislocationGeneral disorders | 32/2019 | 3/751 |
| PneumoniaInfections and infestations | 21/2019 | 6/751 |
| Angina pectorisCardiac disorders | 19/2019 | 4/751 |
| SyncopeNervous system disorders | 18/2019 | 3/751 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 17/2019 | 3/751 |
| Chest painGeneral disorders | 14/2019 | 4/751 |
| Medical device changeSurgical and medical procedures | 11/2019 | 0/751 |
| Age, Continuous(years) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Mean | 65.9 ± 12.1 | 61.9 ± 12.1 | 64.8 ± 12.3 |
| Sex: Female, Male(Participants) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Female | 430 | 140 | 570 |
| Male | 1589 | 611 | 2200 |
| Region of Enrollment(participants) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Austria | 44 | 14 | 58 |
| Canada | 119 | 145 | 264 |
| Colombia | 18 | 4 | 22 |
| Czech Republic | 33 | 30 | 63 |
| Denmark | 60 | 42 | 102 |
| Germany | 248 | 57 | 305 |
| India | 7 | 18 | 25 |
| Israel | 104 | 58 | 162 |
| Italy | 61 | 11 | 72 |
| Japan | 144 | 37 | 181 |
| Malaysia | 17 | 2 | 19 |
| Netherlands | 154 | 86 | 240 |
| Saudi Arabia | 121 | 43 | 164 |
| Slovenia | 15 | 0 | 15 |
| South Africa | 7 | 0 | 7 |
| Spain | 24 | 30 | 54 |
| Sweden | 17 | 3 | 20 |
| Switzerland | 13 | 0 | 13 |
| United Arab Emirates | 1 | 4 | 5 |
| United Kingdom | 103 | 11 | 114 |
| United States | 709 | 156 | 865 |
| LVEF(%) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Mean | 31.8 ± 13.0 | 33.3 ± 13.5 | 32.2 ± 13.2 |
| QRS(ms) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Mean | 133.7 ± 33.7 | 107.1 ± 21.9 | 125.9 ± 33.0 |
| Indication(participants) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| Secondary Prevention | 593 | 254 | 847 |
| Primary Prevention | 1426 | 497 | 1923 |
| Heart Failure Status(participants) | DR-ICD/CRT-D | VR-ICD | Total |
|---|---|---|---|
| NYHA I | 232 | 187 | 419 |
| NYHA II | 758 | 346 | 1104 |
| NYHA III | 754 | 99 | 853 |
| NYHA IV | 30 | 8 | 38 |
| No Heart Failure | 245 | 109 | 354 |
| Unknown | 0 | 2 | 2 |
Showing the first 100 of 122 sites across 21 countries.
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure