An interventional study of Bi-ventricular Implantable Cardioverter Defibrillator in Tachyarrhythmias, Heart Failure and Ventricular Dysfunction, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Not applicable, Interventional, and Treatment
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).
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.
189 studies on the registry are indexed under Tachycardia; 24 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 117 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator
Device: Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Also known as: ConsultaTM
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
Adverse Events
Number of Adverse Events reported in the implanted subjects.
Time frame: 1 month
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
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
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
| Milestone | Consulta Implant |
|---|---|
| Started | 83 |
| Completed | 80 |
| Not completed | 3 |
| Withdrew: Device not implanted | 3 |
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.
| percentage of patients | Consulta Implant |
|---|---|
| Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | 100 (90 to 100) |
Number of Adverse Events reported in the implanted subjects.
| number of adverse events | Consulta Implant |
|---|---|
| Adverse Events | 70 |
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.
| number of Holter recordings | Consulta Implant |
|---|---|
| System Performance Assessed by Holter Records | 20 |
94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
| number of Save to Disk files | Implantation of Consulta CRT-D |
|---|---|
| System Performance Assessed by Save to Disk Files | 94 |
Reported technical observations will be reviewed to determine if there are any device performance issues.
| number of Technical Observations | Implantation of Consulta CRT-D |
|---|---|
| System Performance Assessed by Technical Observations | 3 |
Collected over From implant to 1 month follow-up visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Consulta Implant | 0/80 (0%) | 18/80 (22.5%) | 33/80 (41.3%) |
| Event | Consulta Implant |
|---|---|
| Lead dislodgementInjury, poisoning and procedural complications | 4/80 |
| Ventricular tachycardiaCardiac disorders | 3/80 |
| Cardiac FailureCardiac disorders | 2/80 |
| Abdominal PainGastrointestinal disorders | 1/80 |
| Atrial FibrillationCardiac disorders | 1/80 |
| Atypical AnginaCardiac disorders | 1/80 |
| Sinus TachycardiaCardiac disorders | 1/80 |
| Cardiac PerforationSurgical and medical procedures | 1/80 |
| EpistaxisInjury, poisoning and procedural complications | 1/80 |
| HemorrhoidsGastrointestinal disorders | 1/80 |
| Event | Consulta Implant |
|---|---|
| Cardiac FailureCardiac disorders | 5/80 |
| Elevated pacing thresholdsInjury, poisoning and procedural complications | 4/80 |
| Atrial fibrillationCardiac disorders | 3/80 |
| Phrenic nerve stimulationInjury, poisoning and procedural complications | 3/80 |
| Cardiac failureCardiac disorders | 2/80 |
| Lung infectionRespiratory, thoracic and mediastinal disorders | 2/80 |
| DizzinessNervous system disorders | 2/80 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/80 |
| Implant site haematomaInjury, poisoning and procedural complications | 2/80 |
| Implant site painInjury, poisoning and procedural complications | 2/80 |
| Age, Categorical(Participants) | Consulta Implant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 47 |
| Age, Continuous(years) | Consulta Implant |
|---|---|
| Mean | 66.0 ± 10.18 |
| Sex: Female, Male(Participants) | Consulta Implant |
|---|---|
| Female | 19 |
| Male | 62 |
| Region of Enrollment(participants) | Consulta Implant |
|---|---|
| Germany | 23 |
| Israel | 15 |
| United Kingdom | 11 |
| Netherlands | 7 |
| Norway | 6 |
| Denmark | 5 |
| Switzerland | 5 |
| Austria | 4 |
| France | 3 |
| Sweden | 2 |
The record gives a start of Oct 2007, a primary completion of Jan 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2009, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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