Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

NCT04747353 | Completed

• 1 other identifier: CHUBX 2021/01
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 2

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-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed

Conditions

Ventricular Tachycardia

Keywords

Myocardial infarction; Ventricular Tachycardia; Catheter Ablation; Imaging; Cardiac computed tomography

Outcome Measures

Primary Outcomes (1)

• evaluation of image-guided VT ablation protocol

  Feasibility of the image-guided VT ablation protocol, defined by the presence of all following criteria: * CT imaging acquisition completed (yes/no) * pseudonymized images transferred to core lab (yes/no) * image processing/3D modeling completed by corelab (yes/no) * 3D model transferred to site within 24h of image acquisition (yes/no) * 3D model registered in the 3D mapping system during catheter ablation procedure (yes/no) * all CT-channels targeted by radiofrequency ablation, regardless of local and procedural outcomes (yes/no)

  end of catheter ablation procedure (hour 3)

Secondary Outcomes (16)

• Rate of acute success after CT-channels ablation

  end of catheter ablation procedure (hour 3)

• Number of VTs persisting after CT channel ablation

  end of catheter ablation procedure (hour 3)

• Cycle lengths of VTs persisting after CT channel ablation

  end of catheter ablation procedure (hour 3)

• Location of VTs persisting after CT channel ablation

  end of catheter ablation procedure (hour 3)

• Rate of acute success at the end of the procedure

  end of catheter ablation procedure (hour 3)

Study Arms (1)

Catheter ablation procedure with heart 3D model

EXPERIMENTAL

Experimental: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets

Device: Catheter ablation procedure with heart 3D model

Interventions

Catheter ablation procedure with heart 3D model DEVICE

Device: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets

Catheter ablation procedure with heart 3D model

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• European Commission: collaborator

Study Sites (2)

Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux

Pessac, France

Location

Heart Centre, Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 10, 2021
• Study Start: May 4, 2021
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

FR (1); CH (1)