Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter II
2016-IMR
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this clinical study is to assess the safety and performance of the Vision-MR Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse events related to the device or procedure; the primary performance endpoint will measure the acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1 atrial flutter at three months post-ablation procedure. The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. The study population will consist of adult patients requiring ablation for type I atrial flutter. This is the follow-up study to NCT02699034.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedFebruary 19, 2019
February 1, 2019
9 months
December 10, 2016
February 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients with bidirectional cavo-tricuspid isthmus block after intervention
Acute success defined as the demonstration of the established electrophysiological endpoint (e.g. bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus) with the investigational device. Historically, the acute success rate for RF ablation of type I atrial flutter is 85%. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S achieving success, the percentage, represented as P, will be calculated as P = 100\*S/N.
9 months
Number of patients with periinterventional serious adverse events
The primary safety endpoint is the rate of serious adverse events (SAEs) related to the device or procedure assessed at the 7-day follow-up. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S experiencing an SAE related to the device or procedure, the percentage, represented as P, will be calculated as P = 100\*S/N.
9 months
Number of patients with freedom from recurrence from type I atrial flutter 3 months (chronic success rate) after ablation (study procedure).
The primary chronic performance endpoint is the chronic success rate defined as freedom from recurrence of type 1 atrial flutter at 3 months post procedure. Freedom of recurrence of type I atrial flutter is assessed using symptom survey, ECG and echocardiogram data. This will be evaluated separately for all subjects treated with the device and for all subjects that achieved acute success (defined by the primary acute performance endpoint).
9 month
Secondary Outcomes (1)
Number of patients with freedom from recurrence from type I atrial flutter 6 months after ablation (study procedure).
9 month
Study Arms (1)
ablation for typical atrial flutter
EXPERIMENTALThis group receives an MR-guide ablation for atrial flutter with the study device ( Vision-MR ablation catheter )
Interventions
Typical atrial flutter is treated by catheter ablation.
The study device is used inside the MRI environment to localize the cavotricuspid isthmus (CTI). The CTI is then treated with radiofrequency energy to achieve complete isthmus block.
Eligibility Criteria
You may qualify if:
- First time indication for ablation for type I atrial flutter.
- Patients willing and able (mentally and physically capable per physician's discretion) to understand the investigational nature, potential risks and benefits of the study and able to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
- Patients able to receive anticoagulation therapy to achieve adequate anticoagulation
You may not qualify if:
- Contraindication for MRI diagnostic exam
- A cardiac ablation or cardiac surgery within 180 days prior to enrollment
- Documented intracardiac thrombus, tumor, bleeding, clotting or other abnormality that precludes catheter introduction and placement
- Myocardial infarction within 60 days prior to enrollment
- Current unstable angina
- History of cerebrovascular event (within 180 days prior to enrollment)
- Patients with an ejection fraction less than or equal to 35% within 90 day prior to enrollment
- Permanent leads in or through the right atrium
- Clinically significant structural heart disease (including tricuspid valve regurgitation, tricuspid valve stenosis or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator
- Uncompensated congestive heart failure (NYHA Class III or IV)
- Arrhythmia is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
- Known sensitivity to heparin or warfarin
- Active or systemic infection
- Any other significant uncontrolled or unstable medical condition (including but not limited to hypertension and diabetes)
- contraindication for conventional ablation procedure know allergy against radiocontrast agents renal insufficiency with glomerular filtration rate \< 30ml/min/1,73m2
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- Heart Center Leipzig - University Hospitalcollaborator
- Philips Healthcarecollaborator
- Imricor Medical Systemcollaborator
Study Sites (1)
Heart Center Leipzig
Leipzig, Saxony, 04289, Germany
Related Publications (2)
Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.
PMID: 26316146BACKGROUNDGrothoff M, Gutberlet M, Hindricks G, Fleiter C, Schnackenburg B, Weiss S, Krueger S, Piorkowski C, Gaspar T, Wedan S, Lloyd T, Sommer P, Hilbert S. Magnetic resonance imaging guided transatrial electrophysiological studies in swine using active catheter tracking - experience with 14 cases. Eur Radiol. 2017 May;27(5):1954-1962. doi: 10.1007/s00330-016-4560-7. Epub 2016 Aug 23.
PMID: 27553931BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- This an Open Label study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2016
First Posted
March 14, 2017
Study Start
March 30, 2017
Primary Completion
December 11, 2017
Study Completion
January 15, 2019
Last Updated
February 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share