Heart Failure, Tachyarrhythmias, Ventricular Dysfunction
Conditions
Brief summary
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
Detailed description
The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy. The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers. To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
Interventions
DEVICEBi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have an indication for a defibrillator. * Patients who are optimally treated with medication. * Patients who are New York Heart Association (NYHA) Class III or IV
Exclusion criteria
* Patients with a life expectancy less than the duration of the study. * Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients. * Patients with mechanical tricuspid heart valves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | 1 month | Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 month | Number of Adverse Events reported in the implanted subjects. |
| System Performance Assessed by Holter Records | 1 month follow-up | The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias. |
| System Performance Assessed by Save to Disk Files | 1 month follow-up | 94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias. |
| System Performance Assessed by Technical Observations | 1 month follow-up | Reported technical observations will be reviewed to determine if there are any device performance issues. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Consulta Implant Patients implanted with a Consulta Cardiac Resynchronization Therapy (CRT)-D device | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device not implanted | 3 |
Baseline characteristics
| Characteristic | Consulta Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 47 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 66.0 years STANDARD_DEVIATION 10.18 |
| Region of Enrollment Austria | 4 participants |
| Region of Enrollment Denmark | 5 participants |
| Region of Enrollment France | 3 participants |
| Region of Enrollment Germany | 23 participants |
| Region of Enrollment Israel | 15 participants |
| Region of Enrollment Netherlands | 7 participants |
| Region of Enrollment Norway | 6 participants |
| Region of Enrollment Sweden | 2 participants |
| Region of Enrollment Switzerland | 5 participants |
| Region of Enrollment United Kingdom | 11 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 33 / 80 |
| serious Total, serious adverse events | 18 / 80 |
Outcome results
Primary
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
Time frame: 1 month
Population: Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Consulta Implant | Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | 100 percentage of patients |
p-value: <0.03One proportion binomial exact
Secondary
Adverse Events
Number of Adverse Events reported in the implanted subjects.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Consulta Implant | Adverse Events | 70 number of adverse events |
Secondary
System Performance Assessed by Holter Records
The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Time frame: 1 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Consulta Implant | System Performance Assessed by Holter Records | 20 number of Holter recordings |
Secondary
System Performance Assessed by Save to Disk Files
94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Time frame: 1 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Consulta Implant | System Performance Assessed by Save to Disk Files | 94 number of Save to Disk files |
Secondary
System Performance Assessed by Technical Observations
Reported technical observations will be reviewed to determine if there are any device performance issues.
Time frame: 1 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Consulta Implant | System Performance Assessed by Technical Observations | 3 number of Technical Observations |