AzTrials
AzTrials

Tachycardia, VentricularPhase 4SMSNCT00170287

SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)

A Phase 4 study testing ICD Ablation plus VT-ablation and ICD Therapy in people with Tachycardia, Ventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Tachycardia, Ventricular
What is being tested?
ICD Ablation plus VT-ablation and ICD Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
7 sitesin 2 countries
Study dates
May 2002to Aug 2011
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.
  • Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.
  • Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:
  • Hypotensive VT without major neurologic dysfunction;
  • Syncope; or
  • Cardiac arrest.

Who cannot join

  • Age < 18 years or > 80 years
  • Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram
  • Acute myocardial infarction within the preceding 2 months
  • Class IV New York Heart Association (NYHA) heart failure
  • Valvular heart disease or mechanical heart valve precluding access to the left ventricle
  • Unstable angina
Show all 16Show fewer
  • Cardiac surgery within the past 2 months
  • Serum creatinine > 220 mmol/L (2.5 mg/dL)
  • Thrombocytopenia or coagulopathy
  • Contraindication to heparin
  • Pregnancy
  • Acute illness or active systemic infection
  • Other disease process likely to limit survival to less than 12 months
  • Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study
  • Participation in another investigational study
  • Unwillingness to participate or lack of availability for follow-up

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Germany6 sites

  • Herz- und Gefäßklinik GmbH

    Bad Neustadt / Saale, 97616

  • Berufsgenossenschaftliche Kliniken Bergmannsheil

    Bochum, 44789

  • Klinikum der J.W. Goethe Universität

    Frankfurt, 60590

  • Allgemeines Krankenhaus St. Georg

    Hamburg, 20099

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20251

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen, 67063

Other trials in Germany

Denmark1 site

  • Skejby Skygehus

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: Substrate Modification Study in Patients Getting an ICD

The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions.

The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.

Being tested
ICD Ablation plus VT-ablation, ICD Therapy
Keywords
Unstable 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 Ablation plus VT-ablationProcedure or surgery

    ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification

  • ICD TherapyDevice

    ICD Therapy for the Treatment of unstable VT´s

Study groups in NCT00170287
Study groupRoleWhat they receive
1ExperimentalICD Therapy plus VT-Ablation
Receives: Procedure: ICD Ablation plus VT-ablation
2Active comparatorICD Therapy only
Receives: Device: ICD Therapy

What is being measured

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

  1. Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period

    Measured: 12 Months

Secondary outcomes (4)

  1. All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)

    Measured: 12 Months

  2. Quality of life

    Measured: 12 Months

  3. Number of hospital readmissions due to a cardiac indication

    Measured: 12 Months

  4. Severe clinical events

    Measured: 12 Months

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startMay 2002
  3. Primary completionApr 2010
  4. Study completionAug 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00170287
Sponsor's protocol ID
CEN_G_CA_3
Acronym
SMS
Status last verified
Sep 2017
First submitted
9 Sep 2005
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, Willems S; SMS Investigators. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004422. doi: 10.1161/CIRCEP.116.004422.

    PubMed 28292751

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ICD Ablation plus VT-ablation and ICD Therapy in people with Tachycardia, Ventricular, run by Medtronic Cardiac Rhythm and Heart Failure at 7 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 6 inclusion and 16 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period (time frame: 12 Months). 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 NCT00170287, 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 3 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in