Electrophysiology StudyNCT07094256
Torque Device Evaluation
A study testing Peritorq in people with Electrophysiology Study and Ablation, run by University of Minnesota at 2 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Electrophysiology Study, Ablation
- What is being tested?
- Peritorq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patient (≤21 years of age)
- Undergoing clinically-indicated electrophysiology study and/or ablation procedure
Who cannot join
- Adult patient (>21 years)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Erick Jimenez, 612-626-2830, jimen191@umn.edu
- Recruiting
Children's National
Washington D.C., District of Columbia, 20010
Charles Berul, 202-476-4132, CBerul@childrensnational.org
About this study
Official title: Evaluation of Novel Torque Device During Electrophysiology Study Procedure
This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.
- Conditions
- Electrophysiology Study, Ablation
- Being tested
- Peritorq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeritorqDevice
Novel torque device specifically designed for electrophysiology and ablation catheters
| Study group | Role | What they receive |
|---|---|---|
| Torque Device | Experimental | After the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place Receives: Device: Peritorq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Impedance
Obtained from catheter at baseline and after Peritorq device placed
Measured: 15 minutes
Difference in Sensing of Chamber Amplitude (mV)
Obtained from catheter at baseline and after Peritorq device placed
Measured: 15 minutes
Difference in Capture Threshold of Atrium and Ventricle (mA)
Obtained from catheter at baseline and after Peritorq device placed
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrophysiology StudyStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Clark, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094256
- Sponsor's protocol ID
- PEDS-2024-33423
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2025
- Last updated
- 6 Aug 2026
- Results posted
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Torque Device During Electrophysiology Study Procedure
- ClinicalTrials.gov ID
- NCT07094256
- Acronym / sponsor ID
- PEDS-2024-33423
- Conditions
- Electrophysiology Study, Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Torque Device | Experimental | Device: PeritorqAfter the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patient (≤21 years of age)
- Undergoing clinically-indicated electrophysiology study and/or ablation procedure
Key exclusion criteria (1 listed)
- Adult patient (>21 years)
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 |
|---|---|---|
| PeritorqNovel torque device specifically designed for electrophysiology and ablation catheters | Device | Torque Device |
Primary outcome
Difference in Impedance
Time frame: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
Difference in Sensing of Chamber Amplitude (mV)
Time frame: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
Difference in Capture Threshold of Atrium and Ventricle (mA)
Time frame: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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.
Bradley Clark principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritorq in people with Electrophysiology Study and Ablation, run by University of Minnesota at 2 sites in United States.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley Clark ((612) 626-2755, clarkb@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Impedance (time frame: 15 minutes). The study lists 3 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 6 Aug 2026.