Heart FailurePhase 3NCT01193634
Clinical Evaluation Of The PARADYM RF Device
A Phase 3 study testing VR 9250 / DR 9550 / CRT 9750 in people with Heart Failure, run by LivaNova at 1 site in Germany.
Trial summary
The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features: The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- VR 9250 / DR 9550 / CRT 9750
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
- In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
- In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;
Who cannot join
- 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- 2 VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
- 3 VF was caused by electrocution;
- 4 Incessant VT/VF ;
- 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
- 6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
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- 7 Patient is already enrolled in another ongoing clinical study;
- 8 Patient is unable to understand the aim of the study and its procedure;
- 9 Patient refuses to cooperate;
- 10 Patient is unable or refuses to provide informed consent;
- 11 Patient is minor (less than 18-year old);
- 12 Patient is pregnant;
- 13 Patient has life expectancy of less than 1 year;
- 14 Patient is forfeiture of freedom or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform
The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:
The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.
Then, the ICD devices have also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.
Finally the study will report the electrical and handling performances of the new left ventricular lead.
Read the detailed description
In the PARADYM RF clinical study, the sponsor aims at:
- Demonstrating the performances of the right ventricular autothreshold algorithm ;
- Reporting the adverse events documented in the study;
- Reporting electrical performances of Sorin Group PARADYM ICDs, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
- Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
- Reporting the Situs 2 MV left ventricular lead performances;
- Reporting the Situs 2 MV LV lead mechanical handling.
Thus, this study intends to show that PARADYM RF ICDs operate safely and appropriately in intended-use as part of an ICD system.
- Conditions
- Heart Failure
- Being tested
- VR 9250 / DR 9550 / CRT 9750
- Keywords
- ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR 9250 / DR 9550 / CRT 9750Device
Also called 9250 / 9550 / 9750
Active implantable defibrillators range
| Study group | Role | What they receive |
|---|---|---|
| Paradym RF ICD | Experimental | Active implantable defibrillators range Receives: Device: VR 9250 / DR 9550 / CRT 9750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the Right ventricular (RV) autothreshold algorithm performances
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.
Measured: 1 month
Secondary outcomes (4)
Incidence of adverse events
Any adverse event will be documented throughout the study and will be reported.
Measured: 12 months
ICD electrical performances
Report all ICD electrical performances of the Paradym RF ICD.
Measured: 12 months
Evaluation of the left ventricular lead performances
Report the electrical performances and lead mechanical handling at implant.
Measured: 12 months
Evlauation of the Remote Monitoring Solution
Ensure the Home Monitoring setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sack SS Stefan, Pr, Principal investigator, Klinikum Schwabing München Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193634
- Sponsor's protocol ID
- ITSY03 - PARADYM RF STUDY
- Status last verified
- Jun 2014
- First submitted
- 31 Aug 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform
- ClinicalTrials.gov ID
- NCT01193634
- Acronym / sponsor ID
- ITSY03 - PARADYM RF STUDY
- Conditions
- Heart Failure
- Keywords
- ICD VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:
The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.
Then, the ICD devices have also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.
Finally the study will report the electrical and handling performances of the new left ventricular lead.
Detailed description
In the PARADYM RF clinical study, the sponsor aims at:
- Demonstrating the performances of the right ventricular autothreshold algorithm ;
- Reporting the adverse events documented in the study;
- Reporting electrical performances of Sorin Group PARADYM ICDs, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
- Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
- Reporting the Situs 2 MV left ventricular lead performances;
- Reporting the Situs 2 MV LV lead mechanical handling.
Thus, this study intends to show that PARADYM RF ICDs operate safely and appropriately in intended-use as part of an ICD system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paradym RF ICD | Experimental | Device: VR 9250 / DR 9550 / CRT 9750Active implantable defibrillators range |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
- In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
- In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;
Key exclusion criteria (14 listed)
- 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
- 2 VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
- 3 VF was caused by electrocution;
- 4 Incessant VT/VF ;
- 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
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 |
|---|---|---|
| VR 9250 / DR 9550 / CRT 9750Also: 9250 / 9550 / 9750Active implantable defibrillators range | Device | Paradym RF ICD |
Primary outcome
Demonstration of the Right ventricular (RV) autothreshold algorithm performances
Time frame: 1 month
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.
4 secondary outcomes
Incidence of adverse events
Time frame: 12 months
ICD electrical performances
Time frame: 12 months
Evaluation of the left ventricular lead performances
Time frame: 12 months
Evlauation of the Remote Monitoring Solution
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
Sack SS Stefan, Pr principal investigator
Klinikum Schwabing München Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VR 9250 / DR 9550 / CRT 9750 in people with Heart Failure, run by LivaNova 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 14 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 18 Jun 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstration of the Right ventricular (RV) autothreshold algorithm performances (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2014.