Ventricular TachycardiaSPICENCT00745745
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
A study testing Device Implantation in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Abbott Medical Devices at 21 sites in 2 countries.
Trial summary
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Device Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Aug 2008to Jan 2013
- 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
- Age >=18 years
- Signed written informed consent
- Approved indication for implantation of ICD / CRT-D device
Who cannot join
- Preexisting transvenous RV pacemaker or ICD leads
- Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1)
- Hypertrophic obstructive cardiomyopathy
- Presence of intra-aortic balloon pump
- Inotropic drug (not digitalis) necessary for hemodynamic support
- Inability to perform VF induction testing due to anticipated high risk
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- Condition likely to limit cooperation
- Unable to give informed consent
- Pregnancy or planned pregnancy in the next 6 months
- Patients with planned cardiac surgery within the next 3 months following randomization
- Patient is currently participating in a clinical investigation that includes an active treatment arm.
- Acute myocardial infarction within the previous 4 weeks.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
Germany20 sites
Ost-Alb Klinikum
Aalen, 73430
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, 74177
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Städtisches Klinikum Brandenburg
Brandenburg, 14770
Medizinisches Versorgungszentrum
Dachau, 85221
Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
Düren, 52351
Klinikum Esslingen
Esslingen am Neckar, 73730
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, 37073
Asklepios Klinik St. Georg
Hamburg, 20099
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Hennigsdorf, 16761
Krankenhaus Landshut-Achdorf
Landshut, 84036
Universitätsklinikum Leipzig AÖR
Leipzig, 04103
Märkische Kliniken GmbH Klinikum Lüdenscheid
Lüdenscheid, 58515
Kliniken Ludwigsburg-Bietigheim
Ludwigsburg, 71640
Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
Mannheim, 68167
Maria-Hilf Franziskus-Krankenhaus
Mönchengladbach, 41063
Deutsches Herzzentrum Muenchen
Munich, 80636
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, 49074
Klinkum Peine gGmbH
Peine, 31228
About this study
Official title: Septal Positioning of Ventricular ICD Leads
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
Read the detailed description
The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Device Implantation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device ImplantationDevice
Also called CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and, pacemaker- and active fixation ICD-leads
ICD lead implantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Apical ICD lead placement Receives: Device: Device Implantation |
| 2 | Experimental | Mid-Septal ICD lead placement Receives: Device: Device Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival of RV-ICD-lead related complications
Measured: 3 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJan 2013
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 Ventricular TachycardiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Kolb, MD, Principal investigator, Deutsches Herzzentrum München des Freistaates Bayern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745745
- Sponsor's protocol ID
- T83
- Acronym
- SPICE
- Status last verified
- Feb 2019
- First submitted
- 2 Sep 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolb C, Solzbach U, Biermann J, Semmler V, Kloppe A, Klein N, Lennerz C, Szendey I, Andrikopoulos G, Tzeis S, Asbach S; SPICE-investigators. Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study. Int J Cardiol. 2014 Jul 1;174(3):713-20. doi: 10.1016/j.ijcard.2014.04.229. Epub 2014 Apr 26.
PubMed 24838056
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
- Septal Positioning of Ventricular ICD Leads
- ClinicalTrials.gov ID
- NCT00745745
- Acronym / sponsor ID
- SPICE / T83
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Sep 2008 (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.
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
Detailed description
The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Device ImplantationApical ICD lead placement |
| 2 | Experimental | Device: Device ImplantationMid-Septal ICD lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >=18 years
- Signed written informed consent
- Approved indication for implantation of ICD / CRT-D device
Key exclusion criteria (12 listed)
- Preexisting transvenous RV pacemaker or ICD leads
- Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1)
- Hypertrophic obstructive cardiomyopathy
- Presence of intra-aortic balloon pump
- Inotropic drug (not digitalis) necessary for hemodynamic support
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 |
|---|---|---|
| Device ImplantationAlso: CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and, pacemaker- and active fixation ICD-leadsICD lead implantation | Device | 1, 2 |
Primary outcome
Event free survival of RV-ICD-lead related complications
Time frame: 3 months after implantation
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 24838056Kolb C, Solzbach U, Biermann J, Semmler V, Kloppe A, Klein N, Lennerz C, Szendey I, Andrikopoulos G, Tzeis S, Asbach S; SPICE-investigators. Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study. Int J Cardiol. 2014 Jul 1;174(3):713-20. doi: 10.1016/j.ijcard.2014.04.229. Epub 2014 Apr 26.
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Genetic Markers of Cardiovascular Disease in Epilepsy
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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.
Christoph Kolb, MD principal investigator
Deutsches Herzzentrum München des Freistaates Bayern
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Implantation in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Abbott Medical Devices at 21 sites in 2 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 3 inclusion and 12 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 21 sites in Germany, Greece. 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?
Event free survival of RV-ICD-lead related complications (time frame: 3 months after implantation). 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 NCT00745745, 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.