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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00819117
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : February 4, 2019
Sponsor:
Information provided by:
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Cardiac Resynchronization Therapy implant Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
Study Start Date : November 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819117


Locations
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Italy
Ospedale Cisanello
Pisa, Italy, 56126
Azienda Sanitaria Osperaliera Ordine Mauriziano
Torino, Italy, 10128
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Maria Grazia Bongiorni, MD Ospedale Cisanello, Pisa, Italy

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Responsible Party: Angelo Rivetti, Country Manager, St.Jude Medical Italia Spa
ClinicalTrials.gov Identifier: NCT00819117     History of Changes
Other Study ID Numbers: CR05033IT
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Keywords provided by Abbott Medical Devices:
Epicardial leads
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases