Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01798043
First received: February 21, 2013
Last updated: January 6, 2015
Last verified: January 2015
  Purpose

The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).


Condition Intervention
Heart Block
Sick Sinus Syndrome
Atrioventricular Block
Ventricular Dysfunction
Other: Cardiac MRI with pacemaker stimulation
Other: Cardiac MRI with and without pacemaker stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Dyssynchrony [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Strain rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Septal RV lead with >50% pacing (B1)
Cardiac MRI with pacemaker stimulation
Other: Cardiac MRI with pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Experimental: Septal RV lead with <50% pacing (B2)
Cardiac MRI with and without pacemaker stimulation
Other: Cardiac MRI with and without pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Experimental: Apical RV lead with >50% pacing (A1)
Cardiac MRI with pacemaker stimulation
Other: Cardiac MRI with pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Experimental: Apical RV lead with <50% pacing (A2)
Cardiac MRI with and without pacemaker stimulation
Other: Cardiac MRI with and without pacemaker stimulation
Patient is undergoing a Cardiac MRI at enrollment and 12 months later

Detailed Description:

Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.

Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for <50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been implanted with an Accent MRI pacemaker and Tendril MRI leads.
  • Have an RV lead implanted apically (group A) or septally (Group B)
  • Are RV paced for <50% of the time (groups A2 and B2)
  • Are RV paced for > 50% of the time (Groups A1 and B1)
  • Are ≥ 18 years of age.
  • Are able to provide written informed consent.
  • Are willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

  • Have permanent atrial fibrillation with preserved intrinsic conduction
  • Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
  • Have a lead extender, plug or adaptor.
  • Do not have an RV lead implanted apically or septally.
  • Are eligible for groups A1 or B1 but appropriate group already has 20 patients enrolled.
  • Are eligible for groups A2 or B2 but appropriate group already has 5 patients enrolled
  • Are currently participating in another device or drug investigation which includes an active treatment arm.
  • Are pregnant or planning to become pregnant during the duration of the study.
  • Have a life expectancy of less than 12 months from Screening due to any life-threatening condition.
  • Are contraindicated for an MRI scan due to any other reason.
  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: NCT01798043

Contacts
Contact: Heiko Zerlik +41 44 444 24 11 hzerlik@sjm.com

Locations
Switzerland
Stadtspital Triemli Recruiting
Zurich, Switzerland, 8063
Contact: Rainer Zbinden, MD    044 466 1314    rainer.zbinden@triemli.zuerich.ch   
Principal Investigator: Rainer Zbinden, MD         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Rainer Zbinden, MD Triemli Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01798043     History of Changes
Other Study ID Numbers: CR-12-048-CH-LV
Study First Received: February 21, 2013
Last Updated: January 6, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Sick Sinus Syndrome
Ventricular Dysfunction
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 29, 2015