Atrioventricular Block Clinical Trial
— SEPTAL-PMOfficial title:
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 141 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU d'Angers | Angers | |
France | Service de cardiologie-CHU de Brest | Brest | |
France | Service de cardiologie-CHU de Nantes | Nantes | |
France | CHU de Poitiers | Poitiers | |
France | CHU de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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 multicen — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular ejection fraction | 18 months | ||
Secondary | Quality of life questionnaire SF 36 | 18 months | ||
Secondary | NYHA class | 1, 6, 12, 18 months | ||
Secondary | 6-minute-walk test | 1, 18 months | ||
Secondary | LV end-systolic and diastolic volumes | 18 months | ||
Secondary | QRS duration, | 1, 6, 12, 18 months | ||
Secondary | Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage | 18 months | ||
Secondary | All causes and cardiovascular mortality, hospitalizations for cardiovascular cause | 18 months | ||
Secondary | Serious adverse events | 18 months | ||
Secondary | Stimulation and detection ventricular thresholds | 1, 6, 12, 18 months | ||
Secondary | Probes position and electric parameters | 18 months |
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