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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00819117
First received: January 7, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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 Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

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. [ Time Frame: 6 months follow up after implant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819117

Locations
Italy
Ospedale Cisanello
Pisa, Italy, 56126
Azienda Sanitaria Osperaliera Ordine Mauriziano
Torino, Italy, 10128
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Maria Grazia Bongiorni, MD Ospedale Cisanello, Pisa, Italy
  More Information

No publications provided

Responsible Party: Angelo Rivetti, Country Manager, St.Jude Medical Italia Spa
ClinicalTrials.gov Identifier: NCT00819117     History of Changes
Other Study ID Numbers: CR05033IT
Study First Received: January 7, 2009
Last Updated: January 6, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by St. Jude Medical:
Epicardial leads
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014