Comparing two ways of removing the left chest artery for heart bypass
Tests two artery removal methods in people with coronary artery disease.
Key facts
- Who runs it
- Medical University Innsbruck
- Where
- Essen, Freiburg im Breisgau, Giessen, and Jena, GermanySee the 4 sitesAlso in 2 other countries, 4 sites
- Trial code
- Registry title
- Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery
- Status
- Recruiting
- People taking part
- 1,350 people, planned
- Started
- 12 Mar 2024
- Expected to end
- 1 Oct 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- skeletonized harvesting technique
- pedicled harvesting technique
- Record updated
- 15 March 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having a first, stand-alone heart bypass operation for coronary artery disease in several vessels. It compares two ways of taking the left chest artery for the bypass.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Coronary artery disease in several vessels: at least 70% narrowing of the LAD artery and at least 50% narrowing of the circumflex and right coronary areas, with or without at least 50% narrowing of the left main artery.
- Earlier treatment
- Must be having a first, isolated bypass operation (CABG). Previous heart surgery is not allowed.
Main reasons for not taking part
- Emergency operation or minimally invasive bypass surgery
- Previous heart surgery, or other heart or non-heart procedures at the same time
- Planned bypass without the left internal thoracic artery (LITA)
- Chronic kidney disease (GFR <60ml/min/1.73m²) or life expectancy of less than 5 years
- Pregnancy, hyperthyroidism, or contrast agent or iodine allergy
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery)
Who cannot take part
- Preoperative mediastinal radiation therapy
- Minimal invasive coronary artery bypass surgery
- Any concomitant cardiac or non-cardiac procedures
- Previous cardiac surgery
- Known contrast agent allergy
- Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
- Iodine allergy; Intraoperative exclusion criteria:
- Chronic kidney disease (GFR <60ml/min/1.73m²)
- Age > 80 years
- Planned CABG without LITA use
- Emergency operation
- Life expectancy of less than 5 years
- Pregnancy
- Hyperthyroidism
- Y/T graft off the LITA graft
- LITA sequential grafting
- LITA target vessel other than LAD
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Germany
Also in 2 other countries, 4 sites
- University of Duisburg-EssenEssen, GermanyContact: Matthias Thielmann, Univ. Prof. Dr.Not yet recruiting
- University of FreiburgFreiburg im Breisgau, GermanyContact: Martin Czerny, Univ. Prof. Dr.Not yet recruiting
- University Hospital GießenGiessen, GermanyContact: Andreas Böning, Univ. Prof. Dr.Not yet recruiting
- University of JenaJena, GermanyContact: Torsten Doenst, Univ. Prof. Dr.Not yet recruiting
About the trial
What the trial wants to find out
Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting.
Read full original descriptionShow less
The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.
The 2 groups in the trial
- skeletonized harvesting techniqueExisting treatment, for comparison
In skeletonized harvesting technique, only the left internal artery itself is harvested.
- pedicled harvesting techniqueExisting treatment, for comparison
In pedicled harvesting technique the left internal thoracic artery, it's accompanying veins and parts of the endothoracic fascia is harvested, creating a 1-2 cm broad pedicle.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Comparison of HARVesting the Left Internal Thoracic Artery in a Skeletonized Versus Pedicled Technique: the HARVITA Trial
- Plain-language title
- Comparing two ways of removing the left chest artery for heart bypassGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05931783, who can take part
- Record updated
- 15 March 2024