TachyarrhythmiasNCT00526162
ConsultaTM CRT-D Clinical Evaluation Study
A study testing Bi-ventricular Implantable Cardioverter Defibrillator in people with Tachyarrhythmias and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- What is being tested?
- Bi-ventricular Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device
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).
Read the 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.
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Being tested
- Bi-ventricular Implantable Cardioverter Defibrillator
- Medical subject headings
- Tachycardia, Heart Failure, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-ventricular Implantable Cardioverter DefibrillatorDevice
Also called ConsultaTM
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Implantation of Consulta CRT-D | Experimental | Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator Receives: Device: Bi-ventricular Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
Adverse Events
Number of Adverse Events reported in the implanted subjects.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachyarrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Consulta Clinical Study Team, Study chair, Medtronic Cardiac Rhythm and Heart Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526162
- Sponsor's protocol ID
- 112
- Status last verified
- Mar 2019
- First submitted
- 6 Sep 2007
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murgatroyd FD, Helmling E, Lemke B, Eber B, Mewis C, van der Meer-Hensgens J, Chang Y, Khalameizer V, Katz A. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Europace. 2010 Jun;12(6):811-6. doi: 10.1093/europace/euq053. Epub 2010 Mar 14.
PubMed 20231152
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device
- ClinicalTrials.gov ID
- NCT00526162
- Acronym / sponsor ID
- 112
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 10 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of Consulta CRT-D | Experimental | Device: Bi-ventricular Implantable Cardioverter DefibrillatorPatients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-ventricular Implantable Cardioverter DefibrillatorAlso: ConsultaTMImplantation of a Bi-ventricular Implantable Cardioverter Defibrillator | Device | Implantation of Consulta CRT-D |
Primary outcome
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
Time frame: 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.
4 secondary outcomes
Adverse Events
Time frame: 1 month
System Performance Assessed by Holter Records
Time frame: 1 month follow-up
System Performance Assessed by Save to Disk Files
Time frame: 1 month follow-up
System Performance Assessed by Technical Observations
Time frame: 1 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20231152Murgatroyd FD, Helmling E, Lemke B, Eber B, Mewis C, van der Meer-Hensgens J, Chang Y, Khalameizer V, Katz A. Manual vs. automatic capture management in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Europace. 2010 Jun;12(6):811-6. doi: 10.1093/europace/euq053. Epub 2010 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Consulta Clinical Study Team study chair
Medtronic Cardiac Rhythm and Heart Failure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-ventricular Implantable Cardioverter Defibrillator in people with Tachyarrhythmias and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.