Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique (INTREPID)

February 1, 2019 updated by: Abbott Medical Devices

INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique

The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.

After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:

  • Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
  • Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).

All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.

Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • Ospedale Cisanello
      • Torino, Italy, 10128
        • Azienda Sanitaria Osperaliera Ordine Mauriziano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
  • Have a stable pharmacological therapy.

Exclusion Criteria:

  • Have a contra-indication to general anesthesia;
  • Have a scheduled cardiac surgery;
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
  • Have a life expectancy of less than 6 months;
  • Are unable to provide informed consent;
  • Are unable to comply with the follow-up schedule and tests;
  • Are minor (age below 18 years);
  • Are pregnant or are planning for pregnancy in the next 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transvenous Lead (TVN CRT)
Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)
Device: Cardiac Resynchronization Therapy implant
Device implant with appropriate leads
Experimental: Epicardial Lead (EPI CRT)
Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)
Device: Cardiac Resynchronization Therapy implant
Device implant with appropriate leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
Time Frame: 6 months follow up after implant
6 months follow up after implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Maria Grazia Bongiorni, MD, Ospedale Cisanello, Pisa, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR05033IT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe