Cardiac ArrhythmiasNCT01642537
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
A study testing Rhythmia Mapping System and the Rhythmia Mapping Catheter in people with Cardiac Arrhythmias, run by Boston Scientific Corporation at 1 site in Canada.
Trial summary
The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Rhythmia Mapping System and the Rhythmia Mapping Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jan 2015
- 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
- Patient understands the implications of participating in the study and provides informed consent
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
- Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia
- Patient can be heparinized during the procedure
Who cannot join
- Patients requiring an emergency ablation procedure
- Patients hemodynamically unstable
- Patients with NYHA Class III or IV heart failure
- Women who are pregnant or lactating
- Patients having cardiac surgery within the past two months
- Patients with Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
Show all 22Show fewer
- Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
- Patients with acute myocardial infarction within 3 months
- Patients awaiting cardiac transplantation
- Patients enrolled in any other clinical study
- Patients with an age <18 or >75 years
- Patients with stable/unstable angina or ongoing myocardial ischemia
- Patients with congenital heart disease (not including atrial septal defect (ASD) or patent foramen ovale (PFO) without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- Patients with pulmonary hypertension (mean or systolic pulmonary artery (PA) pressure > 50mm Hg on Doppler echo)
- Patients with a left atrial diameter > 55 mm
- Patients with any arrhythmia currently being treated where the arrhythmia or the management may interfere with this study
- Patients with active infection or sepsis
- Patients with untreatable allergy to contrast media
- Patients with a history of blood clotting (bleeding or thrombotic) abnormalities
- Patients with any known sensitivities to heparin or warfarin
- Patients with severe chronic obstructive pulmonary disease (COPD) (identified by a forced expiratory volume [FEV1] <1)
- Patients with severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Rhythmia Mapping System and the Rhythmia Mapping Catheter
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmia Mapping System and the Rhythmia Mapping CatheterDevice
Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmia Mapping System & Catheter | Other | This is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter Receives: Device: Rhythmia Mapping System and the Rhythmia Mapping Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major device related adverse cardiac and cerebrovascular events
Measured: 30 days
Device Performance
Measured: 1 day- Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642537
- Sponsor's protocol ID
- TP000-147
- Status last verified
- Jun 2021
- First submitted
- 13 Jul 2012
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
- ClinicalTrials.gov ID
- NCT01642537
- Acronym / sponsor ID
- TP000-147
- Conditions
- Cardiac Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- 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 study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhythmia Mapping System & Catheter | Other | Device: Rhythmia Mapping System and the Rhythmia Mapping CatheterThis is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient understands the implications of participating in the study and provides informed consent
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
- Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia
- Patient can be heparinized during the procedure
Key exclusion criteria (22 listed)
- Patients requiring an emergency ablation procedure
- Patients hemodynamically unstable
- Patients with NYHA Class III or IV heart failure
- Women who are pregnant or lactating
- Patients having cardiac surgery within the past two months
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 |
|---|---|---|
| Rhythmia Mapping System and the Rhythmia Mapping CatheterPatients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure. | Device | Rhythmia Mapping System & Catheter |
Primary outcome
Major device related adverse cardiac and cerebrovascular events
Time frame: 30 days
Device Performance
Time frame: 1 day- Procedure
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 4 Jun 2021.
Related trials for Cardiac Arrhythmias
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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 Rhythmia Mapping System and the Rhythmia Mapping Catheter in people with Cardiac Arrhythmias, run by Boston Scientific Corporation at 1 site in Canada.
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 22 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 4 Jun 2021. 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 Canada. 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?
Major device related adverse cardiac and cerebrovascular events (time frame: 30 days). 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 4 Jun 2021.