Atrial FibrillationRODEO-MaPSNCT04845750
The RODEO Micro Mapping Catheter in Cryoablation Procedures
A study testing Rodeo Micro Mapping Catheter in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by afreeze GmbH at 2 sites in 2 countries.
Trial summary
This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Rodeo Micro Mapping Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Apr 2021to 31 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and legal capacity.
- Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.
- Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
- Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).
Who cannot join
- Indication that the vascular system is not accessible through the left or right groin.
- Indication that a transseptal puncture cannot be performed.
- Any previous ablation or surgery due to AF.
- Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
- Left atrial diameter > 50 mm in the short axis.
- Advanced structural heart disease including
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- moderate-to-severe valvular stenosis or regurgitation,
- previous valve replacement or valve repair,
- congenital heart disease,
- left ventricular ejection fraction < 45% during sinus rhythm,
- congestive heart failure NYHA III or IV,
- coronary artery bypass graft surgery within the last 3 months.
- Permanent pacemaker.
- Pregnant women at the time of the cryoablation procedure.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
- Participation in interventional trials for cardiovascular devices or drugs.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020
Florian Hintringer, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Rhineland-Palatinate, 56564
Burkhard Hügl, MD
About this study
Official title: The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study
This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
- Being tested
- Rodeo Micro Mapping Catheter
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery, Mapping Catheter
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rodeo Micro Mapping CatheterDevice
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Rodeo Micro Mapping Catheter | Experimental | Determination of pulmonary vein isoation during cryoablation procedure Receives: Device: Rodeo Micro Mapping Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Rodeo Micro Mapping Catheter
Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.
Measured: 1-3 hours
Positioning of the Rodeo Micro Mapping Catheter
Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible
Measured: 1-3 hours
Secondary outcomes (8)
Safety of the Rodeo Micro Mapping Catheter.
Percentage of adverse events related to the Rodeo Micro Mapping Catheter
Measured: 1-3 day follow-up period
Efficacy of the Rodeo Micro Mapping Catheter
Percentage of successfully isolated pulmonary veins
Measured: 1-3 hours
Real-time pulmonary vein isolation
Time from beginning of the freeze to conduction blockade (time to effect)
Measured: 1-3 hours
Procedural safety
Procedure-related adverse events
Measured: 1-3 hours
Total procedure time
Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath
Measured: 1-3 hours
Cryoablation catheter procedure time
Cryoablation catheter procedure time defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application
Measured: 1-3 hours
Total fluoroscopy time and dose
Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath
Measured: 1-3 hours
Cryoablation catheter fluoroscopy time and dose
Cryoablation catheter fluoroscopy time and dose defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- afreeze GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Competence Center for Medical Devices GmbH
- Responsible party
- Sponsor
- Investigators
- Florian Hintringer, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845750
- Sponsor's protocol ID
- RODEO-MaPS
- Acronym
- RODEO-MaPS
- Status last verified
- Jul 2022
- First submitted
- 12 Apr 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study
- ClinicalTrials.gov ID
- NCT04845750
- Acronym / sponsor ID
- RODEO-MaPS / RODEO-MaPS
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
- Keywords
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery, Mapping Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- afreeze GmbHUniversity, hospital or other
- Collaborators
- Competence Center for Medical Devices GmbH
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 15 Apr 2021 (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.
This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rodeo Micro Mapping Catheter | Experimental | Device: Rodeo Micro Mapping CatheterDetermination of pulmonary vein isoation during cryoablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and legal capacity.
- Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.
- Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
- Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).
Key exclusion criteria (16 listed)
- Indication that the vascular system is not accessible through the left or right groin.
- Indication that a transseptal puncture cannot be performed.
- Any previous ablation or surgery due to AF.
- Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
- Left atrial diameter > 50 mm in the short axis.
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 |
|---|---|---|
| Rodeo Micro Mapping CatheterThe Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation | Device | Rodeo Micro Mapping Catheter |
Primary outcome
Feasibility of the Rodeo Micro Mapping Catheter
Time frame: 1-3 hours
Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.
Positioning of the Rodeo Micro Mapping Catheter
Time frame: 1-3 hours
Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible
8 secondary outcomes
Safety of the Rodeo Micro Mapping Catheter.
Time frame: 1-3 day follow-up period
Efficacy of the Rodeo Micro Mapping Catheter
Time frame: 1-3 hours
Real-time pulmonary vein isolation
Time frame: 1-3 hours
Procedural safety
Time frame: 1-3 hours
Total procedure time
Time frame: 1-3 hours
Cryoablation catheter procedure time
Time frame: 1-3 hours
Total fluoroscopy time and dose
Time frame: 1-3 hours
Cryoablation catheter fluoroscopy time and dose
Time frame: 1-3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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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.
Florian Hintringer, MD principal investigator
Medical University Innsbruck
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rodeo Micro Mapping Catheter in people with Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by afreeze GmbH at 2 sites in 2 countries.
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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Kaiser, PhD (+43 (0)699 11073109, andreas.kaiser@afreeze.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Rodeo Micro Mapping Catheter (time frame: 1-3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.