Trials Sponsors Conditions Drugs Pricing

Conditions

Adverse Effect of MRI on an Implanted Pacemaker Adverse Effect of MRI on an Implanted Pacemaker Lead

Keywords

bradycardiaMRI scans

Outcome Measures

Primary Outcomes (9)

Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
Implant through 2 months
Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
Implant through 2 months
Freedom From RA Related Complications in the Chronic Period
Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
2 months through 12 months
Freedom From Right Ventricular Lead Related Complications in the Chronic Period
Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit

Secondary Outcomes (3)

Freedom From System-related Complications
Implant through 12 months
Atrial Capture Threshold at the MRI Visit
MRI Scan visit (approx 3 months post implant)
Ventricular Capture Threshold at the MRI Visit
MRI Scan visit (approx 3 months post implant)

Study Arms (2)

Lead Safety

EXPERIMENTAL

Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead

Device: Accent MRI system (lead safety)

Accent MRI system MRI Scan Group

EXPERIMENTAL

Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment

Device: Accent MRI system (with MRI scan)

Interventions

Accent MRI system (lead safety)Device

Patients implanted with an Accent MRI system

Also known as: Accent MRI pacemaker, Tendril MRI lead

Lead Safety

Accent MRI system (with MRI scan)Device

Patients implanted with an Accent MRI system will receive an MRI scan

Also known as:

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Eligible patients will meet all of the following:
Have an approved indication per American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a pacemaker

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (70)

University Hospital of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Heart Center Research

Huntsville, Alabama, 35801, United States

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Mercy Hospital Northwest Arkansas

Rogers, Arkansas, 72758, United States

Central Cardiology

Bakersfield, California, 93308, United States

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Grant Kim, Program Director - Traditional Cardiac Rhythm Management
Organization: Abbott

Study Officials

Grant Kim
Abbott Medical Devices
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

950 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 12, 2012

Study Start

March 30, 2012

Actual (reported)

Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (3)

Study Arms (2)

Lead Safety

Accent MRI system MRI Scan Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (3)

Study Arms (2)

Lead Safety

Accent MRI system MRI Scan Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations