Impact of Septal Vs Apical Pacing on Right and Left Ventr... | NCT01798043

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

NCT01798043

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Jul 24, 2020Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Heart Block
Sick Sinus Syndrome
Atrioventricular Block
Ventricular Dysfunction

Interventions

Cardiac MRI with pacemaker stimulation
Cardiac MRI with and without pacemaker stimulation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to slow enrolment

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 21, 2013

First Submission Date that Met QC Criteria

Feb 21, 2013

First Posted Date

Feb 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cardiac MRI with pacemaker stimulation	Other	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)

Measure	Description	Time Frame
Change in LV chamber volumes.		12 months (baseline to end of study)

Measure	Description	Time Frame
Change in Dyssynchrony		12 months
Change in Ejection fraction		12 months
Change in Strain rate

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Rainer Zbinden, MD	Triemli Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stadtspital Triemli		Zurich		8063	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006327	Heart Block
D012804	Sick Sinus Syndrome
D054537	Atrioventricular Block
D018754	Ventricular Dysfunction

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

Browse Leaves

Not provided

Browse Branches

Not provided