NCT00925691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

6.1 years

First QC Date

June 18, 2009

Last Update Submit

May 22, 2023

Conditions

Atrioventricular Block

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    18 months

Secondary Outcomes (10)

  • Quality of life questionnaire SF 36

    18 months

  • NYHA class

    1, 6, 12, 18 months

  • 6-minute-walk test

    1, 18 months

  • LV end-systolic and diastolic volumes

    18 months

  • QRS duration,

    1, 6, 12, 18 months

  • +5 more secondary outcomes

Study Arms (2)

APICAL

ACTIVE COMPARATOR

implantation at the apex

Device: RV lead

SEPTAL

EXPERIMENTAL

implantation at the interventricular septum

Device: RV lead

Interventions

RV leadDEVICE

The RV lead is implanted at the apex or at the interventricular septum

APICALSEPTAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU d'Angers

Angers, 49000, France

Location

Service de cardiologie-CHU de Brest

Brest, 29000, France

Location

Service de cardiologie-CHU de Nantes

Nantes, 44000, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU de Rennes

Rennes, 35000, France

Location

Related Publications (1)

  • 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.

    PMID: 35221255RESULT

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Leclercq, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 22, 2009

Study Start

April 1, 2010

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(5)