Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

NCT01528150 | Completed Results

• 1 other identifier: CR-11-054-EU-LV
• Study Type: observational
• Target: 466
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• Freedom From RA and RV Lead-related Complications

  Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.

  up to 12 months post-implant

Study Arms (1)

Accent MRI System

Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

standard bradycardia indications

You may qualify if:

• Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
• Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
• Is ≥ 18 years of age.
• Able to provide written informed consent prior to any investigational related procedure.
• Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if:

• Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
• Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).
• 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.
• Have a prosthetic tricuspid heart valve.
• Are currently participating in another investigational device or drug investigation.
• Are allergic to Dexamethasone sodium phosphate (DSP).
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director Clinical Studies
• Organization: St. Jude Medical

aoza@sjm.com

+1 818 493 3648

Study Officials

• Rob RW Breedveld, MD

  Medical Center Leeuwarden, the Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: March 1, 2015
• Last Updated: February 4, 2019
• Results First Posted: August 31, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share