Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique (INTREPID)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Epicardial leads, Cardiac Resynchronization Therapy
Eligibility 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.
Sites / Locations
- Ospedale Cisanello
- Azienda Sanitaria Osperaliera Ordine Mauriziano
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Transvenous Lead (TVN CRT)
Epicardial Lead (EPI CRT)
Arm Description
Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)
Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00819117
First Posted
January 7, 2009
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00819117
Brief Title
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
Acronym
INTREPID
Official Title
INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Epicardial leads, Cardiac Resynchronization Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transvenous Lead (TVN CRT)
Arm Type
Active Comparator
Arm Description
Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)
Arm Title
Epicardial Lead (EPI CRT)
Arm Type
Experimental
Arm Description
Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy implant
Intervention Description
Device implant with appropriate leads
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Grazia Bongiorni, MD
Organizational Affiliation
Ospedale Cisanello, Pisa, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Cisanello
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Sanitaria Osperaliera Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
We'll reach out to this number within 24 hrs