Atrial FlutterNCT02768051
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
A study testing AF Ablation in people with Atrial Flutter, run by EPD Solutions, A Philips Company.
Trial summary
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter. Prospective, single-center, non-randomized, open label, single arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- AF Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2016
- 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
- Subject is at least 18 years of age.
- Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
- Subject is generally in good health.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
- Subject is deemed amenable to therapeutic ablation for atrial flutter.
Who cannot join
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Patient has a pacemaker.
- Thrombi detected in the heart.
- Known marked valvar insufficiency.
- Life expectancy less than 12 months.
- Known severe renal insufficiency.
About this study
Official title: EP Dynamics (EPD) Research First In Man Clinical Study
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.
Read the detailed description
All procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the D700 system will be used additionally to demonstrate system safety, feasibility and usability.
The entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.
- Conditions
- Atrial Flutter
- Being tested
- AF Ablation
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AF Ablation Intervention | Experimental | Subjects who are scheduled to undergo ablation procedure due to atrial flutter. Receives: Procedure: AF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint - Any intra-procedural or immediate post-procedure complications.
Measured: Intra-procedural or immediate post-procedure
Secondary outcomes (2)
Feasibility - Freedom from any impact on current workflow or clinical efficacy.
Measured: Intra-procedural or immediate post-procedure
Usability - Correct visualization of the catheter spatial location (map reference).
Measured: Intra-procedural or immediate post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016 (estimated)
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Business decision of the management
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768051
- Sponsor's protocol ID
- CLN-D700-001
- Status last verified
- May 2018
- First submitted
- 1 May 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EP Dynamics (EPD) Research First In Man Clinical Study
- ClinicalTrials.gov ID
- NCT02768051
- Acronym / sponsor ID
- CLN-D700-001
- Conditions
- Atrial Flutter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision of the management
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2016 (estimated)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 May 2016 (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.
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.
Detailed description
All procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the D700 system will be used additionally to demonstrate system safety, feasibility and usability.
The entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF Ablation Intervention | Experimental | Procedure: AF AblationSubjects who are scheduled to undergo ablation procedure due to atrial flutter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age.
- Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
- Subject is generally in good health.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Key exclusion criteria (8 listed)
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Patient has a pacemaker.
- Thrombi detected in the heart.
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 |
|---|---|---|
| AF Ablation | Procedure or surgery | AF Ablation Intervention |
Primary outcome
Safety Endpoint - Any intra-procedural or immediate post-procedure complications.
Time frame: Intra-procedural or immediate post-procedure
2 secondary outcomes
Feasibility - Freedom from any impact on current workflow or clinical efficacy.
Time frame: Intra-procedural or immediate post-procedure
Usability - Correct visualization of the catheter spatial location (map reference).
Time frame: Intra-procedural or immediate post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing AF Ablation in people with Atrial Flutter, run by EPD Solutions, A Philips Company.
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 8 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: withdrawn, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety Endpoint - Any intra-procedural or immediate post-procedure complications. (time frame: Intra-procedural or immediate post-procedure). 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 17 May 2018.