Product Performance Report: Evaluate Long-term Reliabilit... | NCT00271180

Studies
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

NCT00271180

Sponsor

Medtronic

Status

Recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Arrhythmia
Bradycardia
Heart Failure
Sinus Tachycardia

Interventions

Device

Countries

United States
Australia
Austria
Belgium
Canada
China
Czechia
Denmark
Finland
France
Germany
Greece
Hong Kong
Hungary
Iceland
India
Israel
Italy
Japan
Kuwait
Malaysia
Netherlands
New Zealand
Norway
Poland
Portugal
Saudi Arabia
Serbia
Slovakia
Slovenia
South Korea
Spain
Sweden
Switzerland
United Kingdom

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

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1983Actual

Primary Completion Date

Dec 2040Estimated

Completion Date

Dec 2040Estimated

First Submitted Date

Dec 28, 2005

First Submission Date that Met QC Criteria

Dec 28, 2005

First Posted Date

Dec 30, 2005Estimated

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

May 5, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Detailed Description

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Device	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lead related complications for each lead model.	All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.	Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria:

• Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB

AND one of the following must also apply:

Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data

Exclusion Criteria:

Subjects who are, or will be inaccessible for follow-up
Subjects with exclusion criteria required by local law (EMEA only)
Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects implanted with Medtronic qualifying cardiac rhythm product.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
	Recruiting	Birmingham	Alabama		United States

ID	Term
D001145	Arrhythmias, Cardiac
D001919	Bradycardia
D006333	Heart Failure
D013616	Tachycardia, Sinus

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013617	Tachycardia, Supraventricular
D013610	Tachycardia
D000075224	Cardiac Conduction System Disease