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Protego DF4 Post Approval Registry
trial in Implantable Defibrillator User in 1,694 participants. Terminated before completion.
| Lead sponsor | Biotronik, Inc. |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 1,694 |
| Start date | 27 September 2014 |
| Primary completion | 17 April 2019 |
| Estimated completion | 17 April 2019 |
| Sites | 68 locations across United States |
Biotronik, Inc. — full company profile →
18 and older, any sex, with Implantable Defibrillator User. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 98.7 | 98.04 – 99.18 |
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.41 | 0.17 – 0.85 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.30 | 0.10 – 0.69 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.18 | 0.03 – 0.55 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.12 | 0.01 – 0.43 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.12 | 0.01 – 0.43 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.06 | 0.01 – 0.33 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.06 | 0.01 – 0.33 |
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.06 | 0.01 – 0.33 |
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 0.67 | ± 0.36 |
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 71.5 | ± 13.4 |
The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 90.73 | 89.25 – 92.07 |
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 15.70 | ± 5.97 |
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
| Group | Value | 95% CI |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | 552.3 | ± 121.5 |
Time frame: Up to 4.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BIOTRONIK Protego DF4 Lead |
|---|---|---|
| RV lead dislodgement | Cardiac disorders | — |
| Atrial lead dislodgement | Cardiac disorders | — |
| Primary infection | Infections and infestations | — |
| RV lead oversensing not due to external noise | Cardiac disorders | — |
| Hematoma | Surgical and medical procedures | — |
| Secondary infection | Infections and infestations | — |
| LV lead dislodgement | Cardiac disorders | — |
| RV lead conductor fracture | Cardiac disorders | — |
| LV lead diaphragmatic stimulation | Cardiac disorders | — |
| RV lead high pacing threshold | Cardiac disorders | — |
| RV lead impedance out of range, high impedance | Cardiac disorders | — |
| RV lead impedance out of range, low impedance | Cardiac disorders | — |
| LV lead high pacing threshold | Cardiac disorders | — |
| Premature battery depletion | Cardiac disorders | — |
| RV lead undersensing or loss of sensing | Cardiac disorders | — |
| Pneumothorax | Surgical and medical procedures | — |
| Atrial lead conductor fracture | Cardiac disorders | — |
| Cardiac perforation | Cardiac disorders | — |
| LV lead intermittent capture / no lead capture | Cardiac disorders | — |
| RV lead intermittent capture / no lead capture | Cardiac disorders | — |
| Twiddler's syndrome | General disorders | — |
| Skin erosion | Skin and subcutaneous tissue disorders | — |
| Cardiac perforation with or without tamponade | Surgical and medical procedures | — |
| Coronary sinus dissection | Surgical and medical procedures | — |
| Loose set-screw | Surgical and medical procedures | — |
| Reaction | System | BIOTRONIK Protego DF4 Lead |
|---|---|---|
| LV lead high pacing threshold | Cardiac disorders | — |
| LV lead diaphragmatic stimulation | Cardiac disorders | — |
| Atrial lead high pacing threshold | Cardiac disorders | — |
| RV lead high pacing threshold | Cardiac disorders | — |
| Atrial lead dislodgement | Cardiac disorders | — |
| LV lead intermittent capture / no lead capture | Cardiac disorders | — |
| Pulse generator back-up mode initiated | Cardiac disorders | — |
| Atrial lead impedance out of range, high impedance | Cardiac disorders | — |
| Inability to extend helix during implant procedure | Cardiac disorders | — |
| RV lead oversensing not due to external noise | Cardiac disorders | — |
| Hematoma | Surgical and medical procedures | — |
| Bent connector pin noted during implant procedure | Cardiac disorders | — |
| Lightheadedness | General disorders | — |
| Atrial lead impedance out of range, low impedance | Cardiac disorders | — |
| Atrial lead intermittent capture / no lead capture | Cardiac disorders | — |
| Inability to successfully implant Protego lead | Cardiac disorders | — |
| LV lead dislodgement | Cardiac disorders | — |
| LV lead impedance out of range, high impedance | Cardiac disorders | — |
| LV lead oversensing not due to external noise | Cardiac disorders | — |
| RV lead diaphragmatic stimulation | Cardiac disorders | — |
| RV lead impedance out of range, high impedance | Cardiac disorders | — |
| RV lead impedance out of range, low impedance | Cardiac disorders | — |
| RV lead intermittent capture / no lead capture | Cardiac disorders | — |
| RV lead undersensing or loss of sensing | Cardiac disorders | — |
| Skin erosion | Skin and subcutaneous tissue disorders | — |
| Damage to lead during procedure (e.g. accidental cut to lead body during pocket revision, device rep | Surgical and medical procedures | — |
| Inability to successfully implant Protego lead due to patient anatomy | Surgical and medical procedures | — |
| Pocket pain | Surgical and medical procedures | — |
| RA lead dislodgement during a procedure | Surgical and medical procedures | — |
| RV lead dislodgement during a procedure | Surgical and medical procedures | — |
| Venous occlusion | Surgical and medical procedures | — |
| Venous thrombosis without pulmonary embolism | Surgical and medical procedures | — |
Most-reported serious reactions: RV lead dislodgement, Atrial lead dislodgement, Primary infection, RV lead oversensing not due to external noise, Hematoma, Secondary infection, LV lead dislodgement, RV lead conductor fracture.
Data from ClinicalTrials.gov NCT02243696 adverse events section.
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing