Atrioventricular BlockPhase 3SEPTAL-PMNCT00925691
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
A Phase 3 study testing RV lead in people with Atrioventricular Block, run by Rennes University Hospital at 5 sites in France.
Trial summary
The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block
- What is being tested?
- RV lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2010to May 2016
- Phase
- Phase 3
- 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 over 18 years old.
- Written informed consent.
- Permanent cardiac pacing indication for high degree AV block with ventricular rate less than 50 bpm according to the current guidelines of the European Society of Cardiology .
- Patients with sinus rhythm or permanent atrial fibrillation.
- Non-inclusion Criteria:
- Indication for cardiac resynchronization.
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- Indication for Intra cardiac defibrillators (ICD).
- Indication for AV node ablation for patients with atrial fibrillation.
- Patients already implanted with a pacemaker or an ICD.
- Myocardial infarction within the previous month.
- Surgically treated valvulopathy.
- Tricuspid Valve prothesis
- Cardiac surgery or coronary revascularization planned or within the 3 last months.
- Life expectancy less than 18 months.
- Pregnancy.
- Disability to give informed consent.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU d'Angers
Angers, 49000
Service de cardiologie-CHU de Brest
Brest, 29000
Service de cardiologie-CHU de Nantes
Nantes, 44000
CHU de Poitiers
Poitiers, 86000
CHU de Rennes
Rennes, 35000
About this study
The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.
Read the detailed description
Classically the right ventricular pacing (RV) lead position is the RV apex. Several small studies suggested that the septal position which provided a more physiological conduction pattern would improve left ventricular function and dimensions and the patients' outcome.
The SEPTAL-PM study is a parallel randomized prospective simple-blinded and multicenter national study with a follow-up duration of 18 month. A total of 180 patients will be enrolled.
It was designed to demonstrate that in patients requiring permanent RV pacing for high degree atrio-ventricular conduction disorders the septal pacing would preserve the LVEF and LV dimensions but also the quality of life and the exercise tolerance.
The primary endpoint is the evolution of the LVEF assessed by contrast echocardiography. The secondary endpoints are: the quality of life SF 36 questionnaire, the NYHA class, the 6-minute-walk test, the QRS duration, the LV end-systolic and diastolic volumes, the NT-pro BNP, MMP 2-9 and TIMP-1 dosages, stimulation and detection ventricular thresholds.
Other reported parameters are: the probes position and electric parameters, all causes of mortality, cardiovascular mortality, hospitalisations for cardiovascular causes, serious adverse events.
- Conditions
- Atrioventricular Block
- Being tested
- RV lead
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV leadDevice
The RV lead is implanted at the apex or at the interventricular septum
| Study group | Role | What they receive |
|---|---|---|
| APICAL | Active comparator | implantation at the apex Receives: Device: RV lead |
| SEPTAL | Experimental | implantation at the interventricular septum Receives: Device: RV lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Measured: 18 months
Secondary outcomes (10)
Quality of life questionnaire SF 36
Measured: 18 months
NYHA class
Measured: 1, 6, 12, 18 months
6-minute-walk test
Measured: 1, 18 months
LV end-systolic and diastolic volumes
Measured: 18 months
QRS duration,
Measured: 1, 6, 12, 18 months
Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage
Measured: 18 months
All causes and cardiovascular mortality, hospitalizations for cardiovascular cause
Measured: 18 months
Serious adverse events
Measured: 18 months
Stimulation and detection ventricular thresholds
Measured: 1, 6, 12, 18 months
Probes position and electric parameters
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startApr 2010
- Primary completionMay 2016
- Study completionMay 2016
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 Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Leclercq, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925691
- Sponsor's protocol ID
- RCB : 2008-A01027-48
- Other IDs
- LOC / 05-12
- Acronym
- SEPTAL-PM
- Status last verified
- May 2023
- First submitted
- 18 Jun 2009
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Galand V, Martins RP, Donal E, Behar N, Crocq C, Soulie GG, Degand B, Garcia R, Solnon A, Lande G, Probst V, Marjaneh F, Mansourati J, Dupuis JM, Laviolle B, Leclercq C. Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study. Arch Cardiovasc Dis. 2022 May;115(5):288-294. doi: 10.1016/j.acvd.2021.12.007. Epub 2022 Feb 19.
PubMed 35221255
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
- ClinicalTrials.gov ID
- NCT00925691
- Acronym / sponsor ID
- SEPTAL-PM / RCB : 2008-A01027-48
- Conditions
- Atrioventricular Block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jun 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.
The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.
Detailed description
Classically the right ventricular pacing (RV) lead position is the RV apex. Several small studies suggested that the septal position which provided a more physiological conduction pattern would improve left ventricular function and dimensions and the patients' outcome.
The SEPTAL-PM study is a parallel randomized prospective simple-blinded and multicenter national study with a follow-up duration of 18 month. A total of 180 patients will be enrolled.
It was designed to demonstrate that in patients requiring permanent RV pacing for high degree atrio-ventricular conduction disorders the septal pacing would preserve the LVEF and LV dimensions but also the quality of life and the exercise tolerance.
The primary endpoint is the evolution of the LVEF assessed by contrast echocardiography. The secondary endpoints are: the quality of life SF 36 questionnaire, the NYHA class, the 6-minute-walk test, the QRS duration, the LV end-systolic and diastolic volumes, the NT-pro BNP, MMP 2-9 and TIMP-1 dosages, stimulation and detection ventricular thresholds.
Other reported parameters are: the probes position and electric parameters, all causes of mortality, cardiovascular mortality, hospitalisations for cardiovascular causes, serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APICAL | Active comparator | Device: RV leadimplantation at the apex |
| SEPTAL | Experimental | Device: RV leadimplantation at the interventricular septum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age over 18 years old.
- Written informed consent.
- Permanent cardiac pacing indication for high degree AV block with ventricular rate less than 50 bpm according to the current guidelines of the European Society of Cardiology .
- Patients with sinus rhythm or permanent atrial fibrillation.
- Indication for cardiac resynchronization.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RV leadThe RV lead is implanted at the apex or at the interventricular septum | Device | APICAL, SEPTAL |
Primary outcome
Left ventricular ejection fraction
Time frame: 18 months
10 secondary outcomes
Quality of life questionnaire SF 36
Time frame: 18 months
NYHA class
Time frame: 1, 6, 12, 18 months
6-minute-walk test
Time frame: 1, 18 months
LV end-systolic and diastolic volumes
Time frame: 18 months
QRS duration,
Time frame: 1, 6, 12, 18 months
Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage
Time frame: 18 months
All causes and cardiovascular mortality, hospitalizations for cardiovascular cause
Time frame: 18 months
Serious adverse events
Time frame: 18 months
Stimulation and detection ventricular thresholds
Time frame: 1, 6, 12, 18 months
Probes position and electric parameters
Time frame: 18 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 24 May 2023.
- Results publication: PubMed 35221255Galand V, Martins RP, Donal E, Behar N, Crocq C, Soulie GG, Degand B, Garcia R, Solnon A, Lande G, Probst V, Marjaneh F, Mansourati J, Dupuis JM, Laviolle B, Leclercq C. Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study. Arch Cardiovasc Dis. 2022 May;115(5):288-294. doi: 10.1016/j.acvd.2021.12.007. Epub 2022 Feb 19.
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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, PhD principal investigator
Rennes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RV lead in people with Atrioventricular Block, run by Rennes University Hospital at 5 sites in France.
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 16 inclusion and 0 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Left ventricular ejection fraction (time frame: 18 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 NCT00925691, 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 24 May 2023.