Status:
COMPLETED
Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
European Commission
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-opera...
Detailed Description
Background: Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the current approa...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Indication for catheter ablation intervention with planned preoperative cardiac CT scan
- Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury)
- and
- One of the following monomorphic VT events within last 6 months:
- A: ≥3 episodes of symptomatic VT treated with antitachycardia pacing (ATP),
- B: ≥1 appropriate ICD shocks,
- C: ≥3 VT episodes within 24 hr
- D: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor
- E: Sustained VT recorded on 12 leads ECG in the absence of ICD
- Signed informed consent
- Affiliated or beneficiary of health insurance
Exclusion
- Unable or unwilling to provide written informed consent.
- Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
- Have had a prior catheter ablation procedure for VT
- Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF).
- Are in renal failure (Creatinine clearance \<30 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to \<1 year.
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control. (French HAS criteria or following methods are considered adequate):
- Combined hormonal contraception
- Injected hormonal contraception
- Implanted hormonal contraception
- Progesterone-only hormonal contraception associated with inhibition of ovulation
- Placement of an intrauterine device (IUD)
- Placement of intrauterine hormone-realising system (IUS)
- Patient under legal protection.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04747353
Start Date
May 4 2021
End Date
November 21 2022
Last Update
May 1 2023
Active Locations (2)
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1
Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux
Pessac, France
2
Heart Centre, Luzerner Kantonsspital
Lucerne, Switzerland