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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00925691
First received: June 18, 2009
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Atrioventricular Block Device: RV lead Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 141
Study Start Date: April 2010
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: APICAL
implantation at the apex
Device: RV lead
The RV lead is implanted at the apex or at the interventricular septum
Experimental: SEPTAL
implantation at the interventricular septum
Device: RV lead
The RV lead is implanted at the apex or at the interventricular septum

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925691

Locations
France
CHU d'Angers
Angers, France, 49000
Service de cardiologie-CHU de Brest
Brest, France, 29000
Service de cardiologie-CHU de Nantes
Nantes, France, 44000
CHU de Poitiers
Poitiers, France, 86000
CHU de Rennes
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Christophe Leclercq, MD, PhD Rennes University Hospital
  More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00925691     History of Changes
Other Study ID Numbers: RCB : 2008-A01027-48
LOC / 05-12 ( Other Identifier: Rennes University Hospital )
Study First Received: June 18, 2009
Last Updated: August 17, 2016

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2017