Atrial FibrillationFASTR-AFNCT03626649
Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
A study testing DiamondTemp Cardiac Ablation System in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 2 countries.
Trial summary
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DiamondTemp Cardiac Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 May 2018to 8 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
- History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
- (12) months prior to enrollment
- At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
- Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
- Eighteen (18) years of age or above
Who cannot join
- Previous left atrial ablation procedure
- Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
- Known severe cerebrovascular disease or history of cerebrovascular event (< 1 month)
- Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
- Active infection or fever (>100.5 F/38 ◦C)
- Sepsis
Show all 21Show fewer
- Cardiac surgery within the past two months.
- Short life expectancy (<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin < 8.0 mg/dL)
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the last 30 days)
- Documented anaphylaxis during previous exposure to angiographic contrast media
- Uncontrolled congestive heart failure (NYHA1 Class III or IV)
- Unstable angina or acute myocardial infarction within the past three months
- Bleeding, clotting disorders, or known thrombosis
- Severe Peripheral vascular disease
- Uncontrolled diabetes
- Heart valve replacement
- Mitral clip (E-valve)
- Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
- Active participation in another investigational protocol currently or the last 30 days
- Unable or unwilling to take anti-coagulants
- Unwilling or unable to comply with any protocol or follow up requirements
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Clnique du Tonkin
Lyon
CHRU de Nancy
Nancy
Clinique Pasteur
Toulouse
About this study
Official title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
Read the detailed description
- The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
- In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- DiamondTemp Cardiac Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamondTemp Cardiac Ablation SystemDevice
Also called Cardiac ablation
The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of:
- DiamondTemp Ablation Catheter
- Unidirectional and Bidirectional models
- DiamondTemp Catheter-to RFG Cable
- DiamondTemp GenConnect Cable
- DiamondTemp FASTR Generator with Footswitch
- DiamondTemp Irrigation Pump
- DiamondTemp Irrigation Tubing Set
| Study group | Role | What they receive |
|---|---|---|
| DiamondTemp Cardiac Ablation System | Experimental | Cardiac ablation procedure Receives: Device: DiamondTemp Cardiac Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from a composite of serious adverse events (SAE)
Freedom from a composite of serious adverse events (SAE)
Measured: 30 days
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
Measured: 12 months
Secondary outcomes (3)
Freedom from a composite SAE
Freedom from a composite SAE
Measured: 7 days
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
Measured: 12 months
Rate of single procedure success
Rate of single procedure success
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start29 May 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, PhD, Principal investigator, Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626649
- Sponsor's protocol ID
- TP00983
- Acronym
- FASTR-AF
- Status last verified
- Feb 2021
- First submitted
- 8 Aug 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.
PubMed 35581464
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03626649
- Acronym / sponsor ID
- FASTR-AF / TP00983
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 13 Aug 2018 (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 objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
Detailed description
- The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
- In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
| Arm | Type | Receives |
|---|---|---|
| DiamondTemp Cardiac Ablation System | Experimental | Device: DiamondTemp Cardiac Ablation SystemCardiac ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
- History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
- (12) months prior to enrollment
- At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
- Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
Key exclusion criteria (21 listed)
- Previous left atrial ablation procedure
- Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
- Known severe cerebrovascular disease or history of cerebrovascular event (< 1 month)
- Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
- Active infection or fever (>100.5 F/38 ◦C)
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 |
|---|---|---|
| DiamondTemp Cardiac Ablation SystemAlso: Cardiac ablationThe DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: * DiamondTemp Ablation Catheter o Unidirectional and Bidirectional models * DiamondTemp Catheter-to RFG Cable * DiamondTemp GenConnect Cable * DiamondTemp FASTR Generator with Footswitch * DiamondTemp Irrigation Pump * DiamondTemp Irrigation Tubing Set | Device | DiamondTemp Cardiac Ablation System |
Primary outcome
Freedom from a composite of serious adverse events (SAE)
Time frame: 30 days
Freedom from a composite of serious adverse events (SAE)
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
Time frame: 12 months
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
3 secondary outcomes
Freedom from a composite SAE
Time frame: 7 days
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
Time frame: 12 months
Rate of single procedure success
Time frame: 12 months
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 3 Feb 2021.
- Derived from this study: PubMed 35581464Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Petr Neuzil, MD, PhD principal investigator
Na Homolce
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiamondTemp Cardiac Ablation System in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 4 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 6 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Czechia. 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?
Freedom from a composite of serious adverse events (SAE) (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?
On the ClinicalTrials.gov record for NCT03626649, which also lists 1 linked publication.
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 3 Feb 2021.