Tachycardia, VentricularPanoramicNCT00559559

PAtient NOtifier Feature for Reduction of Anxiety

A study testing ICD implant + Patient Notifier turned OFF and ICD Implant + Patient Notifier turned ON in people with Tachycardia, Ventricular, run by Abbott Medical Devices at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tachycardia, Ventricular
What is being tested?: ICD implant + Patient Notifier turned OFF and ICD Implant + Patient Notifier turned ON
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 362 participants
Where: 1 siteSwitzerland
Study dates: Dec 2007to Dec 2010
Phase: Interventional
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

Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
Patient is willing and able to independently comprehend and complete the study-related questionnaires;
Patient has signed the study specific informed consent form.

Who cannot join

have already had a Patient Notifier™ alert since implant;
had a prior device implant (PM or ICD);
have not been discharged from the hospital since device implant;
have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
cannot commit to the follow-up schedule;
have a life expectancy of less than 1 year;

Show all 9Show fewer

are on a waiting list for a heart transplant;
are less than 18 years old;
are pregnant;

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

UniversitätsSpital Zürich
Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study

Conditions: Tachycardia, Ventricular
Being tested: ICD implant + Patient Notifier turned OFF, ICD Implant + Patient Notifier turned ON
Keywords: Primary and secondary prevention for ventricular tachycardia
Medical subject headings: Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICD implant + Patient Notifier turned OFFDevice
ICD implant, plus standard care, i.e. Patient Notifier turned off
ICD Implant + Patient Notifier turned ONProcedure or surgery
ICD implant. The Patient Notifier™ feature will be turned ON.

Study groups in NCT00559559
Study group	Role	What they receive
Control Group	Other	Patient Notifier turned OFF Receives: Device: ICD implant + Patient Notifier turned OFF
Treatment group	Experimental	Patient Notifier turned ON Receives: Procedure: ICD Implant + Patient Notifier turned ON

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)
Measured: 12months

Secondary outcomes (1)

Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality
Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Dec 2010

First posted16 Nov 2007 (estimated)
Study startDec 2007
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00559559
Sponsor's protocol ID: CR06002HV
Acronym: Panoramic
Status last verified: Feb 2019
First submitted: 15 Nov 2007
Last updated: 4 Feb 2019
Results posted: No
Data monitoring committee: No

Publications

Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5.
PubMed 20207746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
ClinicalTrials.gov ID: NCT00559559
Acronym / sponsor ID: Panoramic / CR06002HV
Conditions: Tachycardia, Ventricular
Keywords: Primary and secondary prevention for ventricular tachycardia
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 16 Nov 2007 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Group	Other	Device: ICD implant + Patient Notifier turned OFFPatient Notifier turned OFF
Treatment group	Experimental	Procedure: ICD Implant + Patient Notifier turned ONPatient Notifier turned ON

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
Patient is willing and able to independently comprehend and complete the study-related questionnaires;
Patient has signed the study specific informed consent form.

Key exclusion criteria (9 listed)

have already had a Patient Notifier™ alert since implant;
had a prior device implant (PM or ICD);
have not been discharged from the hospital since device implant;
have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
cannot commit to the follow-up schedule;

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
ICD implant + Patient Notifier turned OFFICD implant, plus standard care, i.e. Patient Notifier turned off	Device	Control Group
ICD Implant + Patient Notifier turned ONICD implant. The Patient Notifier™ feature will be turned ON.	Procedure or surgery	Treatment group

Primary outcome

Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)
Time frame: 12months

1 secondary outcome

Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality
Time frame: 1year

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 4 Feb 2019.
Derived from this study: PubMed 20207746Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5.

Related trials for Tachycardia, Ventricular

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular

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.

Firat Duru, Prof. principal investigator

Universitätsspital Zürich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ICD implant + Patient Notifier turned OFF and ICD Implant + Patient Notifier turned ON in people with Tachycardia, Ventricular, run by Abbott Medical Devices at 1 site in Switzerland.

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 9 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 4 Feb 2019. 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 Switzerland. 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?

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?

Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10) (time frame: 12months). 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 NCT00559559, 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 4 Feb 2019.