Actively Recruiting
A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial
Led by Klinikum-Fuerth · Updated on 2024-10-15
106
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Klinikum-Fuerth
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different catheter ablation methods for treating typical atrial flutter, a heart rhythm disorder. The study compares the conventional linear ablation approach with a newer maximum voltage-guided (MVG) strategy that targets high voltage areas representing key conducting bundles. This prospective randomized trial aims to assess whether the MVG method using MicroFidelity catheter technology with high-resolution mini-electrodes can improve procedure efficiency and reduce radiation exposure while maintaining safety and effectiveness. Participants will be randomly assigned to one of two groups: Group 1 receives the MVG stepwise voltage-guided CTI ablation using IntellaMiFi technology, and Group 2 undergoes the conventional bipolar mapping and linear CTI ablation. Both procedures are performed with or without fluoroscopy as appropriate. The study includes a three-month invasive electrophysiologic follow-up to verify persistent conduction block, followed by clinical assessments and 72-hour Holter monitoring at six and twelve months. During the study, participants will have detailed heart mapping and ablation procedures, with researchers tracking ablation duration, energy delivery, radiation exposure, and adverse events. They will also monitor the success of conduction block and recurrence of atrial flutter over one year. Data security and patient privacy are maintained rigorously, and the study is conducted under ethical guidelines with informed consent. The total participation includes the initial procedure and follow-up visits over a year.
CONDITIONS
Brief Title
Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG
- Given class I indication for curative CTI ablation according to the current guidelines
- Over 18 years old
- Given informed consent
You will not qualify if you...
- Any contraindication for CTI ablation
- Previous CTI ablation
- Bidirectional conduction block (BCB) as procedural endpoint not assessable
- CTI ablation conducted with additional ablation procedures
- Presence of cardiac implantable electronic devices (e.g., pacemaker, ICD)
- Tricuspid valve replacement
- Right atrial thrombus
- Pregnant or breastfeeding women
- Abuse of drugs or alcohol
- Age under 18 years
- Inability to comply with treatment such as necessary anticoagulation
- Expected survival less than one year
- Inability to understand the study's nature and rationale
- Inability to participate in follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the ablation procedure
Participants undergo catheter ablation of the cavotricuspid isthmus (CTI) using either a zero fluoroscopy maximum voltage guided stepwise approach with high-resolution electroanatomic mapping or a conventional linear ablation approach.
1 procedure visit (in-person)
Duration - 12 months
Participants receive a diagnostic electrophysiologic study 3 months after ablation to evaluate the persistence of CTI block. Clinical assessments and 72-hour Holter monitoring are performed at 6 and 12 months post-ablation to monitor for recurrence of atrial flutter.
1 visit at 3 months, 1 visit with Holter monitoring at 6 months, and 1 visit with Holter monitoring at 12 months
Trial Site Locations
Total: 1 location
1
Klinikum Fuerth
Fürth, Bavaria, Germany, 90766
Actively Recruiting
Research Team
D
Dirk Bastian, MD
L
Laura Vitali-Serdoz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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