TachycardiaISIS-ICDNCT01410552

Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

A study testing PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770 in people with Tachycardia, run by MicroPort CRM at 80 sites in 7 countries.

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

ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tachycardia
What is being tested?: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,013 participants
Where: 80 sitesin 7 countries
Study dates: Oct 2011to Feb 2016
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

Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days
Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months

Who cannot join

Any contraindication for ICD therapy
Atrial lead not implanted
Patient with permanent atrial tachyarrhythmia
Patients implanted with a ventricular assist device (VAD)

Trial locations and contacts

80 sites in 7 countries.

Country

City, postcode or hospital

80 sites in 7 countries

United States27 sites

Southern California Electrophysiology Associates
Anaheim, California, 92801
MGH
Boston, Massachusetts
Raymond H. M. Schaerf MD, Inc.
Burbank, California, 91505
Medical University of South Carolina
Charleston, South Carolina, 29403
University of Chicago
Chicago, Illinois
Fairview Hospital
Cleveland, Ohio, 44111
Providence Hospital
Columbia, South Carolina, 29204
St. Tammany Hospital
Covington, Louisiana, 70433
Easton Hospital
Easton, Pennsylvania, 18042
Broward General Medical Center
Fort Lauderdale, Florida, 33316
St. Rose Hospital
Fremont, California, 94538
Pitt Memeorial Hospital Heart Rhythm Associates
Greenville, North Carolina, 27834
Gulfport Memorial Hospital
Gulfport, Mississippi, 39501
H. Raj Reddy Md, Inc.
Hanford, California, 93230
Medical Center of Central Georgia
Macon, Georgia, 31201
Southwest Cardiovascular Associates
Mesa, Arizona, 85205
Pacific Arrhythmia Services
Mesa, Arizona, 91942
Carolina Arrhythmia Consultants
Mt. Pleasant, South Carolina, 29464
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Harlem Cardiology
New York, New York, 10035
Memorial West Hospital
Pembroke Pines, Florida, 33024
Banner Arizona Medical Clinic
Peoria, Arizona, 85381
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Rex Heart and Vascular Specialists
Raleigh, North Carolina, 27607
Louisiana Heart Center
Slidell, Louisiana, 70458
The Toledo Hospital
Toledo, Ohio, 43615

Other trials in United States

France22 sites

Centre Hospitalier Universitaire D'Amiens
Amiens, 80090
Clinique Saint Joseph
Angers
Chu Annecy
Annecy, 74011
CH Henri Duffaut - Avignon
Avignon, 84902
Hôpital Privé de Bois Bernad
Bois-Bernard, 62320
CHRU du Morvan Hôpital la Cavale Blanche
Brest, 29069
Hôpital Instruction des Armées
Clamart, 92141
CH La Rochelle - hôpital St Louis
La Rochelle, 17019
CH LENS
Lens, 62307
Hopital Saint Joseph et saint Luc
Lyon
Centre Hospitalier Universitaire de La Timone
Marseille, 13000
Hopital Nord
Marseille
CH Montpellier
Montpellier
CH Emile Muller
Mulhouse
CHU Groupe Hospitalo-universitaire Caremeau
Nîmes, 30029
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris
Centre Hospitalier
Pau, 64000
CH Périgueux
Périgueux, 24019
CH Yves le Foll
Saint-Brieuc
Centre Hospitalier de Valence
Valence, 26953
CHU Brabois
Vandœuvre-lès-Nancy, 54500

Other trials in France

Japan13 sites

Chiba University Hospital
Chiba
Ichinomiya Nishi Hospital
Ichinomiya, 494-0001
Iizuka Hospital
Iizuka, 820-8505
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
Kokura Memorial Hospital
Kokura
Ohtanishinouchi Hospital
Kōriyama, 963-8558
Tokai University School of Medicine
Tōkai
Shin-Tokyo Hospital
Tokyo
Tokyo Medical and Dental University Hospital
Tokyo
Tokyo Metropolitan Hiroo Hospital
Tokyo
Yamaguchi University Hospital
Ube, 755-8505
Yokohama City University Hospital
Yokohama
Yokohama Rosai general Hospital
Yokosuka, 238-8558

Other trials in Japan

Germany6 sites

Klinikum Bogenhausen
Bogenhausen
Universitatsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23501
UKSH Campus Luebeck
Lübeck, 23562
Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH
Lüneburg, 21339
Kardiologische Praxis Dr. med Taggeselle
Markkleeberg
DRK Krankenhaus Ratzeburg
Ratzeburg

Other trials in Germany

United Kingdom5 sites

Basildon University Hospital
Basildon, England, SS16
Blackpool Victoria Hospital
Blackpool, FY3 8NR
Papworth Everard
Cambridge, CB23 3RE
Dorset County Hospital
Dorchester, DT1 2JY
Kettering Hospital
Kettering

Other trials in United Kingdom

Spain4 sites

Hospital Universitario de la Ribera
Alzira, 46023
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Universitario La Paz
Madrid, 28046
CHU VIGO
Vigo, 3204

Other trials in Spain

Italy3 sites

Policlinico Consorziale di Bari U.O Cardiologia Universitaria
Bari, 70124
Po Melorio
Santa Maria Capua Vetere, 81055
Ospedale S.Andrea
Vercelli, 13100

Other trials in Italy

About this study

Read the detailed description

The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.

Conditions: Tachycardia
Being tested: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
Keywords: Primary prevention, Secondary prevention
Medical subject headings: Tachycardia

What participants receive

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

PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770Device
PARADYM ICD and CRT-d with PARAD+ algorithm available

Study groups in NCT01410552
Study group	Role	What they receive
ICD or CRT-D with PARAD+	Other	only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator Receives: Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770

What is being measured

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

Patients With Inappropriate Shock(s)
Percentage of patients presenting with inappropriate shock(s)
Measured: 552 days

Secondary outcomes (1)

Shock(s) Appropriately Delivered
Percentage of shocks appropriately delivered
Measured: 552 days

Timeline

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

Oct 2011Feb 2016

First posted5 Aug 2011 (estimated)
Study startOct 2011
Primary completionAug 2015
Study completionFeb 2016

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 TachycardiaStudies 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
Model description: ICD device
Masking: None (open label)
Enrolment: 1,013 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01410552
Sponsor's protocol ID: ISIS ICD - ITSY09
Acronym: ISIS-ICD
Status last verified: Mar 2019
First submitted: 3 Aug 2011
Last updated: 22 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, Garcia-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.
PubMed 30910709

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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All Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
ClinicalTrials.gov ID: NCT01410552
Acronym / sponsor ID: ISIS-ICD / ISIS ICD - ITSY09
Conditions: Tachycardia
Keywords: Primary prevention, Secondary prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,013 participants (actual)
Lead sponsor: MicroPort CRMIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Aug 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 5 Aug 2011 (estimated)
Results: Posted 12 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: ICD device

Arm	Type	Receives
ICD or CRT-D with PARAD+	Other	Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator

Who may qualify

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

Key inclusion criteria (2 listed)

Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days
Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months

Key exclusion criteria (4 listed)

Any contraindication for ICD therapy
Atrial lead not implanted
Patient with permanent atrial tachyarrhythmia
Patients implanted with a ventricular assist device (VAD)

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
PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770PARADYM ICD and CRT-d with PARAD+ algorithm available	Device	ICD or CRT-D with PARAD+

Primary outcome

Patients With Inappropriate Shock(s)
Time frame: 552 days
Percentage of patients presenting with inappropriate shock(s)

1 secondary outcome

Shock(s) Appropriately Delivered
Time frame: 552 days

Results and safety

Results posted to the registry on 12 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD or CRT-D With PARAD+	1,013	877

Primary outcome: Patients With Inappropriate Shock(s)

Time frame: 552 days. Number. Unit: Percentage of pts with inap shocks

Measure	Single Arm n = 993
Value	1.4

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Over a median follow up of 552 days (Q1: 354.0; Q3: 725.0).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD or CRT-D With PARAD+	282 of 1,013 (27.8%)	0 of 0	70 of 1,013

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30910709Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, Garcia-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.

Related trials for Tachycardia

Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation

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.

Ricardo RUIZ GRANELL, Dr principal investigator

Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN

Mark RICHARDS, Dr. principal investigator

Toledo Hospital, 4614 Brookside Dr. Toledo (OH)

80 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, France, Japan, Germany, United Kingdom and 2 more countries. 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 12 Feb 2018). 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?

Patients With Inappropriate Shock(s) (time frame: 552 days). 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 NCT01410552, 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 22 Mar 2019.