Status:
COMPLETED
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Lead Sponsor:
Rennes University Hospital
Conditions:
Atrioventricular Block
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-br...
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 improv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00925691
Start Date
April 1 2010
End Date
May 1 2016
Last Update
May 24 2023
Active Locations (5)
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1
CHU d'Angers
Angers, France, 49000
2
Service de cardiologie-CHU de Brest
Brest, France, 29000
3
Service de cardiologie-CHU de Nantes
Nantes, France, 44000
4
CHU de Poitiers
Poitiers, France, 86000