NCT01798043

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

February 21, 2013

Last Update Submit

July 23, 2020

Conditions

Heart BlockSick Sinus SyndromeAtrioventricular BlockVentricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in LV chamber volumes.

    12 months (baseline to end of study)

Secondary Outcomes (3)

  • Change in Dyssynchrony

    12 months

  • Change in Ejection fraction

    12 months

  • Change in Strain rate

    12 months

Study Arms (4)

Septal RV lead with >50% pacing (B1)

EXPERIMENTAL

Cardiac MRI with pacemaker stimulation

Other: Cardiac MRI with pacemaker stimulation

Septal RV lead with <50% pacing (B2)

EXPERIMENTAL

Cardiac MRI with and without pacemaker stimulation

Other: Cardiac MRI with and without pacemaker stimulation

Apical RV lead with >50% pacing (A1)

EXPERIMENTAL

Cardiac MRI with pacemaker stimulation

Other: Cardiac MRI with pacemaker stimulation

Apical RV lead with <50% pacing (A2)

EXPERIMENTAL

Cardiac MRI with and without pacemaker stimulation

Other: Cardiac MRI with and without pacemaker stimulation

Interventions

Cardiac MRI with pacemaker stimulationOTHER

Patient is undergoing a Cardiac MRI at enrollment and 12 months later

Apical RV lead with >50% pacing (A1)Septal RV lead with >50% pacing (B1)
Cardiac MRI with and without pacemaker stimulationOTHER

Patient is undergoing a Cardiac MRI at enrollment and 12 months later

Apical RV lead with <50% pacing (A2)Septal RV lead with <50% pacing (B2)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Heart BlockSick Sinus SyndromeAtrioventricular BlockVentricular Dysfunction

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmia, Sinus

Study Officials

  • Rainer Zbinden, MD

    Triemli Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

CH(1)