Congenital Heart Disease (CHD), Supraventricular Tachycardia (SVT)
Conditions
Keywords
cardiac ablation
Brief summary
The goal of this observational study is to collect real world performance and to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia in adult patients with congenital heart disease: To estimate the rate of acute procedural success and to estimate the rate of chronic success through 6 months post procrdure. Participants will be asked to have a cardiac ablation procedure and visit their doctor at 1 week, 1 month and 6 monhs post procedure.
Detailed description
The MAGiC-CHD Post-Approval Study is a prospective, non-randomized, multi-center, single-arm study to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (CHD) and limited vascular access or difficult access to the target cardiac chamber.
Interventions
DEVICECardiac ablation using the MAGiC Ablation Catheter
This MAGiC ablation catheter is used the the robotic Magnetic System to perform an ablation in a patient who has a SVT. Other patients who are not participaing in this study may have the same proceudre, the procedure with a different catheter, a procedure with a manual catheter, drug therapy or no treatment
Sponsors
Stereotaxis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (aged 18 or older at time of consent). * Clinically indicated for catheter ablation of a supraventricular tachycardia (macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) * History of congenital heart disease with anatomic abnormalities and/or previous surgical interventions and/or previous surgical interventions that limit vascular or target chamber access by conventional manual catheter navigation. * Willing and capable of attending scheduled follow up visits for the study duration = Willing and able to provide informed consent.
Exclusion criteria
* Atrial fibrillation is the target arrhythmia for the catheter ablation. * Unable to be safely exposed to the level of magnetic fields used for Robotic Magnetic Navigation * A history of sensitivity to foreign objects (gold, platinum/iridium, Pebax materials) or extreme allergies. * Acute illness or active systemic infection. * Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection. * Hemodynamic instability (to an extent that would make an interventional procedure high risk). * Presence of intracardiac thrombus. * Where MAGiC would need to cross a prosthetic valve. * Where MAGiC would need to be used in the coronary arteries. * Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation. * Acute myocardial infarct (within the previous 30 days). * Unstable angina at the time of enrollment. * History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days. * Previous cardiac ablation within the last 30 days. * Inaccessible for follow-up visits for 6 months post ablation. * Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study. * Any reason or condition that, in the judgement of the investigator, makes the subject ineligible for the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success | Peri-procedural | Non-indcability of Supraventricular Tachycardia (SVT) |
| Chronic Success | 6 months | subjects free from the treated index arrhythmia through 6 months post procedure. To be counted as recurrence, the recurrent arrhythmia must be the same arrhythmia as primary index arrhythmia and must last at least 30 seconds on Holter monitor or event monitor recording, OR present on the entirety of a 12-lead ECG (minimum recording duration of 10 seconds) OR documented on a personal ECG device recording of a minimum of 30 seconds duration. |
| Acute Safety - Device or peocedure related adverse events | 7 days post procedure | Device or procedure related serioius adverse events which occurred prior to 7 days post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious device related events | 6 months | All serious device related adverse events |
| Acute & Chronic Success | 6 months | Estimating acute procedural success and chronic success by type of target arrhythmia and by specific congenital defect and surgical repair. |
| Procedure time | Peri-procedural | Characterize procedure time from insertion of first sheath to removal of last sheath |
| Fluoroscopy Duration | Peri-procedural | Review of Fluoroscopy duration |
| Hospitlization | 6 months | Estimate the percentage of subjects free from the treated index arrhythmia or procedure related hospitalizations and major adverse events |
| Serious Advere Events | 6 months | Estimate the rate of subjects experiencing serious adverse events by event |
| Quality of Life and arrhythmia burden | 6 months | Estimate the change in subject quality of life and arrhythmia burden. Each question on the form is scored individually and a decreasein values would be considered that the pateint is doing better. The range for each question is from 0-8 or 0-9 dependng in the question |
| Unmet medical need | Peri-procedural | Compilation of the anatomical and clinical challenges unique to the subject population, usage of the MAGiC catheter to address these challenges, and qualitative commentary on performance of MAGiC. |
| Fluoroscopy Dose | Peri-procedural | Review of the dose of DAP used during the procedure |
Contacts
CONTACTBetsy Lowry
CONTACTAashi Mehrotra
PRINCIPAL_INVESTIGATORNathan McConkey, MD
Outcome results
None listed