Model 20105 Lead Study

NCT02301429 | Terminated Results

• 1 other identifier: LV DDD
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.

Conditions

Sick Sinus Node Syndrome

Outcome Measures

Primary Outcomes (1)

• All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.

  All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.

  1 month

Study Arms (1)

Model 20105

EXPERIMENTAL

Receiving the model 20105 Lead

Device: Model 20105

Interventions

Model 20105 DEVICE

implant and follow-up of study device

Model 20105

Eligibility Criteria

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

You may qualify if:

• Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)
• Subject has signed and dated the study-specific informed consent form
• Subject is 18 years of age or older
• Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study

You may not qualify if:

• Subject is indicated for BiV pacemaker or ICD
• Subject is pacing dependent
• Subject has a previous Pacemaker System
• Subject has known coronary venous vasculature that is inadequate for lead placement
• Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
• Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
• Subject is not in sinus rhythm at implant
• Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
• Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
• Subject is contraindicated for \<1mg dexamethasone acetate
• Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
• Subject has a terminal illness and is not expected to survive more than 6 months
• Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
• Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
• Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (4)

London Teaching Hospital

London, Canada

Location

Reinier de Graaf Hospital

Delft, Netherlands

Location

NUHCS, National University Hospital

Singapore, Singapore

Location

Milpark hospital

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Study manager
• Organization: Medtronic Regional Clinical Center

laura.manotta@medtronic.com

0039(0)22 241371

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 26, 2016
• Results First Posted: October 26, 2016

Record last verified: 2016-09

Locations

SG (1); ZA (1); NL (1); CA (1)