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Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing (SEPTAL-PM)

Primary Purpose

Atrioventricular Block

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
RV lead
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'Angers
  • Service de cardiologie-CHU de Brest
  • Service de cardiologie-CHU de Nantes
  • CHU de Poitiers
  • CHU de Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

APICAL

SEPTAL

Arm Description

implantation at the apex

implantation at the interventricular septum

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction

Secondary Outcome Measures

Quality of life questionnaire SF 36
NYHA class
6-minute-walk test
LV end-systolic and diastolic volumes
QRS duration,
Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage
All causes and cardiovascular mortality, hospitalizations for cardiovascular cause
Serious adverse events
Stimulation and detection ventricular thresholds
Probes position and electric parameters

Full Information

First Posted
June 18, 2009
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00925691
Brief Title
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Acronym
SEPTAL-PM
Official Title
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APICAL
Arm Type
Active Comparator
Arm Description
implantation at the apex
Arm Title
SEPTAL
Arm Type
Experimental
Arm Description
implantation at the interventricular septum
Intervention Type
Device
Intervention Name(s)
RV lead
Intervention Description
The RV lead is implanted at the apex or at the interventricular septum
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Quality of life questionnaire SF 36
Time Frame
18 months
Title
NYHA class
Time Frame
1, 6, 12, 18 months
Title
6-minute-walk test
Time Frame
1, 18 months
Title
LV end-systolic and diastolic volumes
Time Frame
18 months
Title
QRS duration,
Time Frame
1, 6, 12, 18 months
Title
Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage
Time Frame
18 months
Title
All causes and cardiovascular mortality, hospitalizations for cardiovascular cause
Time Frame
18 months
Title
Serious adverse events
Time Frame
18 months
Title
Stimulation and detection ventricular thresholds
Time Frame
1, 6, 12, 18 months
Title
Probes position and electric parameters
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Service de cardiologie-CHU de Brest
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Service de cardiologie-CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35221255
Citation
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.
Results Reference
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Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

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