Systolic Heart FailureSEPTAL-CRTNCT00833352
Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
A study testing CRT-D Therapy in people with Systolic Heart Failure and Ventricular Tachycardia, run by Guidant Corporation at 26 sites in 2 countries.
Trial summary
This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- CRT-D Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Nov 2008to Dec 2011
- 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
- Accepted CRT indication according to ESC with
- Documented LVEF </= 35% in last 3 months
- Documented LVEDD ≥ 55 mm or LVEDD > 30 mm/m2, or LVEDD >30 mm/m (height) in last 3 months
- QRS ≥120 ms documented on ECG recording during hospitalisation
- NYHA Class III or ambulatory class IV stable for the last month previous enrolment
- Or the previous criteria 1 and 2 and a transient episode in NYHA class III or IV with prior HF hospitalization or intravenous decongestive therapy (IV diuretics, IV neseritide or IV inotropes) in an "out-patient" setting within the year previous enrolment and stabilization to NYHA class II for the last month with a QRS ≥150 ms documented on ECG recording during hospitalisation
Show all 11Show fewer
- ICD indication (class I or II A)
- Optimal and stable medication for at least one month (except for diuretics stable for minimum 1 week) based on ESC guidelines before the enrolment
- Chronic heart failure (> 3 months) stable for the last month previous enrolment
- Stable sinus rhythm at the enrolment
- Willing and capable of providing informed consent
Who cannot join
- Defibrillation testing not planned during the implant procedure due to a poor haemodynamic or clinical status or other reasons
- Have persistent atrial fibrillation (AF) or atrial flutter (i.e, can be terminated with medical intervention, but does not terminate spontaneously) within 1 month prior inclusion
- Documented AF within 1 month prior enrolment
- Life expectancy < 12 months or expected to undergo heart transplant within the next 12 months
- Uncontrolled blood pressure (Systolic BP > 160 mmHg or Diastolic BP > 85 mmHg)
- Hospitalization for HF or intravenous inotropic drug treatment within 1 month prior enrolment
Show all 12Show fewer
- Cardiac surgery, per cutaneous transluminal angioplasty (PTCA), myocardial infarction (MI), unstable or severe angina or stroke during last 3 months prior enrolment
- Previously implanted pacemaker or ICD
- Uncorrected primary valvular disease
- Prosthetic tricuspid valve
- Nursing women or of childbearing potential who are, or might be pregnant at the time of the study
- Enrolled in any on-going study (including pharmacologic trial).
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
France17 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49033
Hôpital Louis Pradel
Bron, 69677
Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
Grenoble, 38043
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
Hôpital Saint Joseph
Marseille, 13008
Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
Marseille, 13385
Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
Montpellier, 34295
Nouvelles Cliniques Nantaises
Nantes, 44277
Centre Hospitalier Régional d'Orléans- Hôpital La Source
Orléans, 45067
Hôpital La Pitié Salpétrière
Paris, 75013
Centre Hospitalier Universitaire Haut Levêque
Pessac, 33604
Centre Hospitaler Universitaire Pontchaillou
Rennes, 35033
Centre Hospitalier Universitaire-Charles Nicolle
Rouen, 76031
Centre Cardiologique du Nord
Saint-Denis, 93200
Centre Hospitalier Universitaire - Hôpital Rangueil
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
Vandœuvre-lès-Nancy, 54511
Spain9 sites
Hospital general de Alicante
Alicante, 03010
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic I Provincial
Barcelona, 08036
Hospital Puerta de Hierro
Madrid, 28222
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital Virgen de la salud de Toledo
Toledo, 45004
Hospital La Fe
Valencia, 46009
Hospital Universitario Río Hortega
Valladolid, 04710
About this study
This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator.
- Purpose : To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months.
- Objectives:
Read more
The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months.
The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes.
This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study.
All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.
- Being tested
- CRT-D Therapy
- Medical subject headings
- Heart Failure, Systolic, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-D TherapyDevice
Also called Endotak Reliance G and SG
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Right ventricular lead located in Mid Septum Receives: Device: CRT-D Therapy |
| 2 | Active comparator | Right ventricular lead located in Apex Receives: Device: CRT-D Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular end systolic volume (LVESV)
Measured: 6 months
Secondary outcomes (1)
left ventricular end systolic volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionDec 2011
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 Systolic Heart FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Christophe Leclercq, MD, Principal investigator, Hopital Pontchaillou - Rennes- FranceIgnacio Fernández Lozano, MD, Principal investigator, Hospital Puerta de Hierro - Madrid - Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833352
- Sponsor's protocol ID
- SEPTAL CRT 0408
- Acronym
- SEPTAL-CRT
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2009
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Leclercq C, Sadoul N, Mont L, Defaye P, Osca J, Mouton E, Isnard R, Habib G, Zamorano J, Derumeaux G, Fernandez-Lozano I; SEPTAL CRT Study Investigators. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study. Eur Heart J. 2016 Feb 1;37(5):473-83. doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15.
PubMed 26374852
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
- ClinicalTrials.gov ID
- NCT00833352
- Acronym / sponsor ID
- SEPTAL-CRT / SEPTAL CRT 0408
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Feb 2009 (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 prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator.
- Purpose : To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months.
- Objectives:
The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months.
The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes.
This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study.
All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CRT-D TherapyRight ventricular lead located in Mid Septum |
| 2 | Active comparator | Device: CRT-D TherapyRight ventricular lead located in Apex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Accepted CRT indication according to ESC with
- Or the previous criteria 1 and 2 and a transient episode in NYHA class III or IV with prior HF hospitalization or intravenous decongestive therapy (IV diuretics, IV neseritide or IV inotropes) in an "out-patient" setting within the year previous enrolment and stabilization to NYHA class II for the last month with a QRS ≥150 ms documented on ECG recording during hospitalisation
- ICD indication (class I or II A)
- Optimal and stable medication for at least one month (except for diuretics stable for minimum 1 week) based on ESC guidelines before the enrolment
- Chronic heart failure (> 3 months) stable for the last month previous enrolment
Key exclusion criteria (12 listed)
- Defibrillation testing not planned during the implant procedure due to a poor haemodynamic or clinical status or other reasons
- Have persistent atrial fibrillation (AF) or atrial flutter (i.e, can be terminated with medical intervention, but does not terminate spontaneously) within 1 month prior inclusion
- Documented AF within 1 month prior enrolment
- Life expectancy < 12 months or expected to undergo heart transplant within the next 12 months
- Uncontrolled blood pressure (Systolic BP > 160 mmHg or Diastolic BP > 85 mmHg)
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 |
|---|---|---|
| CRT-D TherapyAlso: Endotak Reliance G and SGImplant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles. | Device | 1, 2 |
Primary outcome
left ventricular end systolic volume (LVESV)
Time frame: 6 months
1 secondary outcome
left ventricular end systolic volume
Time frame: 12 months
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 30 Jan 2014.
- Derived from this study: PubMed 26374852Leclercq C, Sadoul N, Mont L, Defaye P, Osca J, Mouton E, Isnard R, Habib G, Zamorano J, Derumeaux G, Fernandez-Lozano I; SEPTAL CRT Study Investigators. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study. Eur Heart J. 2016 Feb 1;37(5):473-83. doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15.
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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.
Christophe Leclercq, MD principal investigator
Hopital Pontchaillou - Rennes- France
Ignacio Fernández Lozano, MD principal investigator
Hospital Puerta de Hierro - Madrid - Spain
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-D Therapy in people with Systolic Heart Failure and Ventricular Tachycardia, run by Guidant Corporation at 26 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 11 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Spain. 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?
left ventricular end systolic volume (LVESV) (time frame: 6 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 NCT00833352, 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 30 Jan 2014.