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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00925691
First received: June 18, 2009
Last updated: September 11, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life questionnaire SF 36 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • NYHA class [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • 6-minute-walk test [ Time Frame: 1, 18 months ] [ Designated as safety issue: No ]
  • LV end-systolic and diastolic volumes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • QRS duration, [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • All causes and cardiovascular mortality, hospitalizations for cardiovascular cause [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Stimulation and detection ventricular thresholds [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Probes position and electric parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Christophe Leclercq, MD, PhD christophe.leclercq@chu-rennes.fr

Locations
France
CHU d'Angers Recruiting
Angers, France, 49000
Contact: Jean-Marc DUPUIS, MD         
Principal Investigator: Jean-Marc DUPUIS, MD         
Service de cardiologie-CHU de Brest Recruiting
Brest, France, 29000
Contact: Marjaneh FATEMI, MD         
Principal Investigator: Marjaneh FATEMI, MD         
Hôpital Privé Sévigné Not yet recruiting
Cesson Sévigné, France, 35576
Contact: Chistophe CROCQ, MD         
Principal Investigator: Chistophe CROCQ, MD         
Service de cardiologie-CHU de Nantes Recruiting
Nantes, France, 44000
Contact: Aude Solnon, MD         
Principal Investigator: Aude Solnon, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Bruno DEGAND, MD         
Principal Investigator: Bruno DEGAND, MD         
CHU de Rennes Recruiting
Rennes, France, 35000
Contact: Christophe LECLERCQ, MD, PhD         
Principal Investigator: Christophe LECLERCQ, MD, PhD         
CHU de Tours Not yet recruiting
Tours, France, 37000
Contact: Dominique BABUTY, MD         
Principal Investigator: Dominique BABUTY, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Christophe Leclercq, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00925691     History of Changes
Other Study ID Numbers: RCB : 2008-A01027-48, LOC / 05-12
Study First Received: June 18, 2009
Last Updated: September 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 25, 2014