Atrial FibrillationSR-TheAFNCT05461612
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
A study testing Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device in people with Atrial Fibrillation, run by Maxwell Biomedical at 1 site in Georgia.
Trial summary
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation. 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?
- Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGeorgia
- Study dates
- 23 Jun 2022to Dec 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
- Have AF that persists (Persistent AF) for more than 7 days but less than 1 year; OR has required cardioversion for termination of AF in the past 6 months; AND is not due to a reversible cause.
- Be scheduled to undergo open-heart surgery
- Be able to adhere to follow-up requirements
Who cannot join
- Have active pericarditis or any systemic infection
- Have left atrial thrombus (including left atrial appendage)
- Have had a previous attempt to ablate atrial fibrillation
- Scheduled for left atrial exclusion or excision
- Have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion
- Have NYHA Class IV heart failure
Show all 11Show fewer
- Have long-standing persistent or permanent AF
- Long-standing persistent AF is defined as AF that persists for greater than 1 year
- Permanent AF is defined as AF where termination (sinus rhythm) is no longer pursued
- Have any condition that prevents placement of a catheter on the posterior wall of the left atrium
- History of Left Atrium (LA) infarction
Trial locations and contacts
1 site in 1 country.
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi
+995 322 479 300, heartvasc@hotmail.com
George Khabeishvili, MD
About this study
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
Read the detailed description
This is an acute study to test the ability of a custom external device (MAX-SRS) to sense atrial rhythms, determine when AF is present and deliver spatial resynchronization therapy (SRT) to terminate AF.
Patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. The catheters will be connected to the MAX-SRS. If AF is not present, standard pacing measures will be used to induce AF. Once > 1 minute of AF is recorded, the MAX-SRS will be activated to sense the rhythm and deliver SRT pacing to terminate the AF. Up to five SRT deliveries using the same or different SRT algorithms will be attempted. After the first successful termination of AF or after five SRT attempts the study is complete for each patient. Diagnostic catheters will be removed after the conclusion of the SRT pacing study.
- Conditions
- Atrial Fibrillation
- Being tested
- Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
- Keywords
- Atrial Fibrillation, Spatial Resynchronization
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation deviceDevice
Also called SRT, MAX-SRS
Delivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| SRT Pacing | Experimental | SRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm. Receives: Device: Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of test system (MAX-SRS) to record AF
Record 1 run of AF = 60 seconds, categorical variable (Yes/No)
Measured: 60 seconds
Mean SRT pacing duration per SRT pacing attempt
Record duration (min:sec) of each SRT pacing attempt
Measured: min:sec/attempt
Secondary outcomes (1)
Mean SRT pacing duration to convert AF
Record duration (min:sec) of SRT pacing and organization of clinical rhythm (conversion to arrhythmia other than AF) or AF termination.
Measured: Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start23 Jun 2022
- Primary completionJun 2023 (estimated)
- Study completionDec 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxwell Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Khabeishvili, MD, Principal investigator, Tbilisi Heart and Vascular Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461612
- Sponsor's protocol ID
- CLP22-001
- Acronym
- SR-TheAF
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 18 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05461612
- Acronym / sponsor ID
- SR-TheAF / CLP22-001
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Spatial Resynchronization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxwell BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jul 2022 (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.
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
Detailed description
This is an acute study to test the ability of a custom external device (MAX-SRS) to sense atrial rhythms, determine when AF is present and deliver spatial resynchronization therapy (SRT) to terminate AF.
Patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. The catheters will be connected to the MAX-SRS. If AF is not present, standard pacing measures will be used to induce AF. Once > 1 minute of AF is recorded, the MAX-SRS will be activated to sense the rhythm and deliver SRT pacing to terminate the AF. Up to five SRT deliveries using the same or different SRT algorithms will be attempted. After the first successful termination of AF or after five SRT attempts the study is complete for each patient. Diagnostic catheters will be removed after the conclusion of the SRT pacing study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRT Pacing | Experimental | Device: Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation deviceSRT sensing and pacing of the left atrium to detect AF and restore sinus rhythm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have AF that persists (Persistent AF) for more than 7 days but less than 1 year; OR has required cardioversion for termination of AF in the past 6 months; AND is not due to a reversible cause.
- Be scheduled to undergo open-heart surgery
- Be able to adhere to follow-up requirements
Key exclusion criteria (11 listed)
- Have active pericarditis or any systemic infection
- Have left atrial thrombus (including left atrial appendage)
- Have had a previous attempt to ablate atrial fibrillation
- Scheduled for left atrial exclusion or excision
- Have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion
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 |
|---|---|---|
| Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation deviceAlso: SRT, MAX-SRSDelivery of algorithmically defined pacing stimuli over a multitude of electrodes placed on the left atrium. | Device | SRT Pacing |
Primary outcome
Ability of test system (MAX-SRS) to record AF
Time frame: 60 seconds
Record 1 run of AF = 60 seconds, categorical variable (Yes/No)
Mean SRT pacing duration per SRT pacing attempt
Time frame: min:sec/attempt
Record duration (min:sec) of each SRT pacing attempt
1 secondary outcome
Mean SRT pacing duration to convert AF
Time frame: Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
George Khabeishvili, MD principal investigator
Tbilisi Heart and Vascular Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device in people with Atrial Fibrillation, run by Maxwell Biomedical at 1 site in Georgia.
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 3 inclusion and 11 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 18 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 1 site in Georgia. 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 George Khabeishvili, MD (+995 599 502 255, georgekhabeishvili@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of test system (MAX-SRS) to record AF (time frame: 60 seconds). 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 18 Jul 2022.