Atrial Flutter2016-IMRNCT03078985
Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter II
A study testing ablation for typical atrial flutter and catheter ablation with study device in people with Atrial Flutter, run by University of Leipzig at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- ablation for typical atrial flutter and catheter ablation with study device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 30 Mar 2017to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
- Women who are pregnant or plan to become pregnant within the course of their participation in the investigation or who are breastfeeding
- Life expectancy of less than 12 months
- Patients with prosthetic valves
- Contraindicated for transfemoral venous access
- Older than 75 years
- Current enrollment in any other clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter
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.
Read the detailed description
The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. 35 subjects subjects meeting inclusion/exclusion criteria will participate in the study. This study requires the use of investigational products from two independent manufacturers: Imricor and Philips. Imricor has developed the ablation catheter with related accessory cables and electrophysiology (EP) recorder/stimulator system. Philips has developed an image guidance and mapping system that is compatible with the Imricor products.
The Vision-MR Ablation Catheter will be used in conjunction with the following investigational products: Vision-MR Ablation Cable Set, Vision-MR Diagnostic Cable, the interventional MRI Suite (iSuite) image guidance and mapping system, and a dStream Interface (dSIF-FE). With the exception of iSuite and dSIF-FE, which are manufactured by Philips, Imricor will provide all investigational devices used in the study.
Each procedure will require two single-use Vision-MR Ablation Catheters and one each of the two single-use accessory catheter cables.
Ablation for the treatment of arrhythmia is an inherently complex procedure. Use of the investigational products listed above under MR guidance is an emerging approach to performing the interventional electrophysiology procedure.
The study population will consist of adult patients requiring ablation for type I atrial flutter.
Study subjects will require a follow-up visit or telephone call at seven days post procedure. Accordingly, the expected total study duration is approximately 9 months with study start planned for February 2017.
This is the follow-up study to NCT02699034 which was terminated early based on a recommendation by the oversight authority. The study device (Vision-MR ablation catheter) has been improved and the EP recorder/stimulator is now CE-marked.
- Conditions
- Atrial Flutter
- Being tested
- ablation for typical atrial flutter, catheter ablation with study device
- Keywords
- real-time MRI, electrophysiology study, atrial flutter ablation, active tracking
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation for typical atrial flutterProcedure or surgery
Typical atrial flutter is treated by catheter ablation.
catheter ablation with study deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ablation for typical atrial flutter | Experimental | This group receives an MR-guide ablation for atrial flutter with the study device ( Vision-MR ablation catheter ) Receives: Procedure: ablation for typical atrial flutter; Device: catheter ablation with study device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 9 month
Secondary outcomes (1)
Number of patients with freedom from recurrence from type I atrial flutter 6 months after ablation (study procedure).
The secondary performance endpoint is the chronic success rate defined as freedom from recurrence of type 1 atrial flutter at 6 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 chronic success (defined by the primary chronic acute performance endpoint).
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start30 Mar 2017
- Primary completion11 Dec 2017
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Philips Healthcare, Imricor Medical Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078985
- Sponsor's protocol ID
- 2016-IMR
- Acronym
- 2016-IMR
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26316146Grothoff 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.
PubMed 27553931
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter
- ClinicalTrials.gov ID
- NCT03078985
- Acronym / sponsor ID
- 2016-IMR / 2016-IMR
- Conditions
- Atrial Flutter
- Keywords
- real-time MRI, electrophysiology study, atrial flutter ablation, active tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Philips Healthcare, Imricor Medical Systems
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. 35 subjects subjects meeting inclusion/exclusion criteria will participate in the study. This study requires the use of investigational products from two independent manufacturers: Imricor and Philips. Imricor has developed the ablation catheter with related accessory cables and electrophysiology (EP) recorder/stimulator system. Philips has developed an image guidance and mapping system that is compatible with the Imricor products.
The Vision-MR Ablation Catheter will be used in conjunction with the following investigational products: Vision-MR Ablation Cable Set, Vision-MR Diagnostic Cable, the interventional MRI Suite (iSuite) image guidance and mapping system, and a dStream Interface (dSIF-FE). With the exception of iSuite and dSIF-FE, which are manufactured by Philips, Imricor will provide all investigational devices used in the study.
Each procedure will require two single-use Vision-MR Ablation Catheters and one each of the two single-use accessory catheter cables.
Ablation for the treatment of arrhythmia is an inherently complex procedure. Use of the investigational products listed above under MR guidance is an emerging approach to performing the interventional electrophysiology procedure.
The study population will consist of adult patients requiring ablation for type I atrial flutter.
Study subjects will require a follow-up visit or telephone call at seven days post procedure. Accordingly, the expected total study duration is approximately 9 months with study start planned for February 2017.
This is the follow-up study to NCT02699034 which was terminated early based on a recommendation by the oversight authority. The study device (Vision-MR ablation catheter) has been improved and the EP recorder/stimulator is now CE-marked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ablation for typical atrial flutter | Experimental | Procedure: ablation for typical atrial flutter, Device: catheter ablation with study deviceThis group receives an MR-guide ablation for atrial flutter with the study device ( Vision-MR ablation catheter ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ablation for typical atrial flutterTypical atrial flutter is treated by catheter ablation. | Procedure or surgery | ablation for typical atrial flutter |
| catheter ablation with study deviceThe 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. | Device | ablation for typical atrial flutter |
Primary outcome
Number of patients with bidirectional cavo-tricuspid isthmus block after intervention
Time frame: 9 months
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.
Number of patients with periinterventional serious adverse events
Time frame: 9 months
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.
Number of patients with freedom from recurrence from type I atrial flutter 3 months (chronic success rate) after ablation (study procedure).
Time frame: 9 month
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).
1 secondary outcome
Number of patients with freedom from recurrence from type I atrial flutter 6 months after ablation (study procedure).
Time frame: 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 26316146Hilbert 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.
- Background: PubMed 27553931Grothoff 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.
- Imricor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablation for typical atrial flutter and catheter ablation with study device in people with Atrial Flutter, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with bidirectional cavo-tricuspid isthmus block after intervention (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.