Atrial FibrillationNCT04939584
Patient Perception of MultiPulse Therapy™ (MPT™)
A study testing MultiPulse Therapy in people with Atrial Fibrillation, run by Cardialen, Inc. at 2 sites in Australia.
Trial summary
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MultiPulse Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesAustralia
- Study dates
- 19 Nov 2021to 1 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 80 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- History of Atrial Fibrillation in past 12 months
- Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study
- Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator
- Study stage dependent: Stage 1:
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- 6a. History of DC-Cardioversion in past 12 months: With or Without
- 7b. AFEQT Score: <=89
- Study stage dependent: Stage 2 (based on results from study stage 1):
- 6a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV
- 7b. AFEQT Score: Potential emphasis on patients with AFEQT <= 58
Who cannot join
- Life expectancy of 1 year or less
- AF due to reversible causes (e.g., hyperthyroidism, valve disease)
- Hx of fibromyalgia or any other evidence of wide-spread pain
- Any current pain condition that could be confused with pain or discomfort associated with MPT
- >1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)
- Use of any opioid analgesic (including tramadol) within 3 months of screening
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- Spielberger's STAI-AD-Trait > 75
- AFEQT: Section 1: "I was never aware of having atrial fibrillation" is checked
- Allergy or contraindication to anticoagulation therapy
- Presence of intracardiac thrombus (confirmed with cardiac imaging)
- Existing Left Atrial Appendage closure device
- LVEF<20%
- NYHA Class IV heart failure at the time of enrollment
- History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
- Known hyper-coagulable state that increases risk of thrombus
- History of myocardial infarction or coronary revascularization within the preceding 3 months.
- History of sustained ventricular arrhythmia or cardiac arrest
- Presence of chronically implanted lead in the CS
- Presence of ventricular assist device, including intra-aortic balloon pump
- Documented bradycardia (<40 BPM) at the time of the study
- Morbid obesity: BMI>39 kg/m2
- Presence of any prosthetic cardiac valve
- History of significant tricuspid valvular disease requiring surgery
- Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
- Cognitive or mental health status that would interfere with study participation and proper informed consent
- Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator's discretion
- Pregnancy confirmed by test within 7 days of procedure.
- Inability to pass catheters to heart due to vascular limitations
- Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
- Active endocarditis
- History of hemodynamic compromise due to valvular heart disease
- Unstable CAD as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
- Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia
St. Andrew's Hospital
Adelaide, South Australia
About this study
Official title: A Clinical Feasibility Study to Evaluate Patient Perception of MPT
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.
Read the detailed description
A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.
- Conditions
- Atrial Fibrillation
- Being tested
- MultiPulse Therapy
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiPulse TherapyDevice
Electrical Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The study will be conducted using the venous cannulations that are standard of care for the indicated procedure. Additional access points may be necessary if access to coronary sinus is difficult from existing femoral venous cannulations. Sterile study leads or EP catheters will be temporarily placed into the RA, CS, and RV (for R-wave sensing using intracardiac electrograms - optional) which will be connected to the investigational device (CESS).
Up to two MPTs will be delivered and subject responses following each MPT regarding perception and acceptability of MPT to treat AF will be obtained. MPT voltages will not exceed 100V. Receives: Device: MultiPulse Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy acceptance as measured by a subject question administered immediately following MPT delivery
Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."
Measured: Immediately following MPT delivery
Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?
Measured: Immediately following MPT delivery
Secondary outcomes (1)
Safety determined from summary report of Adverse Events
Adverse Event frequency by Adverse Event type
Measured: Through 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start19 Nov 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Sponsor ceased operations
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardialen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939584
- Sponsor's protocol ID
- CL008
- Status last verified
- Oct 2022
- First submitted
- 10 Jun 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Feasibility Study to Evaluate Patient Perception of MPT
- ClinicalTrials.gov ID
- NCT04939584
- Acronym / sponsor ID
- CL008
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor ceased operations
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cardialen, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 25 Jun 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.
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.
Detailed description
A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MultiPulse TherapyThe study will be conducted using the venous cannulations that are standard of care for the indicated procedure. Additional access points may be necessary if access to coronary sinus is difficult from existing femoral venous cannulations. Sterile study leads or EP catheters will be temporarily placed into the RA, CS, and RV (for R-wave sensing using intracardiac electrograms - optional) which will be connected to the investigational device (CESS). Up to two MPTs will be delivered and subject responses following each MPT regarding perception and acceptability of MPT to treat AF will be obtained. MPT voltages will not exceed 100V. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female between 18 and 80 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- History of Atrial Fibrillation in past 12 months
- Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study
- Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator
Key exclusion criteria (35 listed)
- Life expectancy of 1 year or less
- AF due to reversible causes (e.g., hyperthyroidism, valve disease)
- Hx of fibromyalgia or any other evidence of wide-spread pain
- Any current pain condition that could be confused with pain or discomfort associated with MPT
- >1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)
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 |
|---|---|---|
| MultiPulse TherapyElectrical Stimulation | Device | Intervention |
Primary outcome
Therapy acceptance as measured by a subject question administered immediately following MPT delivery
Time frame: Immediately following MPT delivery
Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."
Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
Time frame: Immediately following MPT delivery
Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?
1 secondary outcome
Safety determined from summary report of Adverse Events
Time frame: Through 30 days post-intervention
Results and safety
The study was stopped early (reason given: Sponsor ceased operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MultiPulse Therapy in people with Atrial Fibrillation, run by Cardialen, Inc. at 2 sites in Australia.
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 11 inclusion and 35 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: stopped early, as of the sponsor's last update on 10 Oct 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 Australia. 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 was stopped early (reason given: Sponsor ceased operations). Results are not available in the source record.
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?
Therapy acceptance as measured by a subject question administered immediately following MPT delivery (time frame: Immediately following MPT delivery). 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 10 Oct 2022.