Ventricular FibrillationSIMPLENCT00800384
Shockless Implant Evaluation
A study testing Implantable defibrillator in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Boston Scientific Corporation at 85 sites in 18 countries.
Trial summary
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- Implantable defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 85 sitesin 18 countries
- Study dates
- Jan 2009to May 2014
- 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
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Who cannot join
- Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
- Patients on active transplant list
- Patients unwilling to provide informed consent
- Patients not available for follow-up
- Pregnancy or women of child bearing potential not following an effective method of contraception
- Anticipated right sided implantation of the ICD generator
Trial locations and contacts
85 sites in 18 countries.
85 sites in 18 countries
Germany26 sites
Zentralklinik Bad Berka
Bad Berka, 99437
German Heart Center Berlin
Berlin, 13353
Heart Center
Bernau, 16321
Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617
University Hospital Bochum Bergmannsheil
Bochum, 44789
Klinikum Coburg gGmbH
Coburg, 96450
Klinikum Lippe-Detmold
Detmold, 32756
Klinikum Dortmund gGmbH
Dortmund, 44137
University Hospital
Frankfurt, 60590
University Hospital Heidelberg
Heidelberg, 69120
Saarland University Hospital
Homburg/Saar, 66424
Klinikum Kassel
Kassel, 34125
Krankenhaus Landshut Achdorf
Landshut, 84036
Medizinische Klinik und Poliklinik I
Leipzig, 04103
Marienhospital Lünen
Lünen, 44534
University Hospital of Muenster
Münster, 48129
Klinikum Nuernberg Sued
Nuremberg, 90471
Klinikum Oldenburg GmbH
Oldenburg, 26133
Klinikum Ernst von Bergmann gGmbH
Potsdam, 14467
Klinikum der Universitaet Regensburg
Regensburg, 93053
University of Rostock
Rostock, 18057
Herzkreislaufzentrum Rotenburg
Rotenburg an der Fulda, 36199
Krankenhaus der Barmherzigen Brüder
Trier, 54292
University Hospital Tübingen
Tübingen, 72076
University Hospital Ulm
Ulm, 89081
Heinrich Braun Krankenhaus
Zwickau, 08060
Canada13 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Kingston General Hospital
Kingston, Ontario, K7L2V7
London Health Sciences Centre
London, Ontario, N6A 4G5
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
Fleurimont Hospital
Sherbrooke, Quebec, J1H 5N4
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Spain9 sites
Hospital De La Santa Creu I Sant Pau
Barcelona, 08025
Hospital Clinico Y Provincial
Barcelona, 08036
Hospital Universitario Gregorio Maranon
Madrid, 28007
Hospital Clinico San Carlos
Madrid, 28040
Hospital 12 de Octubre Madrid
Madrid, 28041
Hospital La Paz
Madrid, 28046
Clinica Universitaria de Navarra
Pamplona, 31008
Hospital De Navarra
Pamplona, 31008
H. Clinico Universitario
Valencia, 46010
Israel6 sites
Soroka MC
Beersheba, 84101
Carmel Medical Center
Haifa, 34362
Hadassh University Hospital, Mount Scopus
Jerusalem, 91240
Beilinson Medical Center
Petah Tikva, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52621
Netherlands6 sites
Amphia Ziekenhuis
Breda, 4818 CK
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Leiden University Medical Center
Leiden, 2333 ZA
Medisch Centrum Haaglanden (MCH) - locatie Westeinde
The Hague, 2512 VA
Universitair Medisch Centrum
Utrecht, 3584 CX
Isala Klinieken
Zwolle, 8000 GM
France5 sites
CHU Grenoble - Hopital Michallon
Grenoble, 38043
CHRU de Lille
Lille, 59037
CHRU Nancy Brabois
Nancy, 54500
CHG de Pau
Pau, 64046
CHRU Hopital Pontchaillou
Rennes, 35033
Austria4 sites
Landesklinikum St. Poelten
Sankt Pölten, 3100
Allgemeines Krankenhaus Wien
Vienna, 1090
Wilhelminenspital
Vienna, 1160
Klinikum Wels - Grieskirchen
Wels, 4600
Hungary3 sites
Hungarian Institute of Cardiology
Budapest, 1096
Semmelweis University, Cardiovascular Center
Budapest, 1122
Allami Egeszsegugyi Kozpont (AEK) Hospital
Budapest, 1134
United Kingdom3 sites
St. Peters Hospital
Chertsey, KT16 0PZ
Cardiothoracic Centre
Liverpool, L14 3PE
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Poland2 sites
Gornoslaskie Centrum Medyczne
Katowice, 40 635
Polsko-Amerykańske Kliniki Serca
Tychy, 43-100
Czechia1 site
IKEM - Institut klinicke a experimentalni mediciny
Prague, 14021
About this study
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia
- Being tested
- Implantable defibrillator
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable defibrillatorDevice
Also called Study is not device specific., Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.
Implantable defibrillator to detect and terminate ventricular arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ICD implant without defibrillation testing Receives: Device: Implantable defibrillator |
| 2 | Active comparator | ICD implant with defibrillation testing Receives: Device: Implantable defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Measured: Mean follow-up of 3.1 years
Secondary outcomes (1)
Perioperative Complication Rate
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2013
- Study completionMay 2014
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 (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
- Investigators
- Jeff Healey, MD, Principal investigator, Population Health Research Institute CanadaStuart Connolly, MD, Study chair, Population Health Research Institute Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800384
- Sponsor's protocol ID
- 11-2007
- Acronym
- SIMPLE
- Status last verified
- Mar 2014
- First submitted
- 27 Nov 2008
- Last updated
- 30 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.
PubMed 29157723Vamos M, Healey JS, Wang J, Duray GZ, Connolly SJ, van Erven L, Vinolas X, Neuzner J, Glikson M, Hohnloser SH. Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial. Heart Rhythm. 2016 Feb;13(2):504-10. doi: 10.1016/j.hrthm.2015.11.009. Epub 2015 Nov 11.
PubMed 26569461Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.
PubMed 25715991
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockless Implant Evaluation
- ClinicalTrials.gov ID
- NCT00800384
- Acronym / sponsor ID
- SIMPLE / 11-2007
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- Jan 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Posted 22 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Implantable defibrillatorICD implant without defibrillation testing |
| 2 | Active comparator | Device: Implantable defibrillatorICD implant with defibrillation testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Key exclusion criteria (6 listed)
- Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
- Patients on active transplant list
- Patients unwilling to provide informed consent
- Patients not available for follow-up
- Pregnancy or women of child bearing potential not following an effective method of contraception
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 |
|---|---|---|
| Implantable defibrillatorAlso: Study is not device specific., Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.Implantable defibrillator to detect and terminate ventricular arrhythmias | Device | 1, 2 |
Primary outcome
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Time frame: Mean follow-up of 3.1 years
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
1 secondary outcome
Perioperative Complication Rate
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29157723Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.
- Derived from this study: PubMed 26569461Vamos M, Healey JS, Wang J, Duray GZ, Connolly SJ, van Erven L, Vinolas X, Neuzner J, Glikson M, Hohnloser SH. Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial. Heart Rhythm. 2016 Feb;13(2):504-10. doi: 10.1016/j.hrthm.2015.11.009. Epub 2015 Nov 11.
- Derived from this study: PubMed 25715991Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.
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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.
Jeff Healey, MD principal investigator
Population Health Research Institute Canada
Stuart Connolly, MD study chair
Population Health Research Institute Canada
85 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable defibrillator in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Boston Scientific Corporation at 85 sites in 18 countries.
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 6 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Germany, Canada, Spain, Israel, Netherlands and 13 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 22 Dec 2015). 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?
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death (time frame: Mean follow-up of 3.1 years). 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 NCT00800384, which also lists 3 linked publications.
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 30 Mar 2018.