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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01798043
First received: February 21, 2013
Last updated: November 14, 2013
Last verified: November 2013
  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
Heart Block
Sick Sinus Syndrome
Atrioventricular Block
Ventricular Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)
Groups/Cohorts
Septal RV lead with >50% pacing
Septal RV lead with <50% pacing
Apical RV lead with >50% pacing
Apical RV lead with <50% pacing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients previously implanted with a pacemaker system not contraindicated for use in an MRI scanner.

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: Marcus Simon +32 277 46758 msimon@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: November 14, 2013
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 November 25, 2014