Heart BlockNCT06261788
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
A study testing Temporary pacing in people with Heart Block and Valve Heart Disease, run by Swift Sync, Inc. at 1 site in Paraguay.
Trial summary
This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Block, Valve Heart Disease
- What is being tested?
- Temporary pacing
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteParaguay
- Study dates
- 1 Jun 2023to 26 Sep 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
- Subject is undergoing a surgical or an interventional procedure requiring temporary cardiac pacing to support for at least 24 hours per investigator's medical judgement.
- Subject is at least 18 years of age.
- Subject or legal representative provides written informed consent to the study.
Who cannot join
- Subject has a co-exist temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator.
- Subject on cardiogenic shock.
- Subject is currently in atrial fibrillation.
- Subject is pregnant or breastfeeding.
- Subject had a stroke within 6 months prior to enrollment.
- Subject has renal insufficiency with creatinine >2 mg/dl.
Show all 13Show fewer
- Subject with known bleeding diathesis.
- Subject with a history of deep vein thrombosis or pulmonary embolization within 6 months.
- Subject with known tricuspid valve disease that may impede catheter advance to and withdrawn from right ventricle.
- Subject with known intracardiac thrombus or vegetation on echocardiography
- Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult.
- Subject has an active systemic infection or local infection at or around the insertion site.
- Subject is involved in another clinical study that could influence the safety or outcome measures of this study.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Centro de Intervenciones Endovasculares y Cirugia Cardiovascular
Asunción
About this study
Official title: Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)
This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support.
Read the detailed description
The study will enroll up to 31 subjects at one investigational site with at least 3 implanters.
The subjects enrolled will be followed 7 days after the Sync-AV II Temporary Cardiac Pacing Catheter is removed. A safety call or clinic visit at 7 days post discharge will be performed.
Only subjects who meet the inclusion/exclusion criteria and provide informed consent will be eligible to receive the treatment and participate in the study. potential subjects who have a surgical or interventional procedure that will require temporary cardiac pacing support for at least 24 hours per investigator's medical judgement.
The elective surgical or interventional procedure is to be performed per institutional standard of care. Other concomitant therapy (medication and non-medication therapies) may be used during the study for the treatment or prevention of disease or to maintain good health.
Study Procedure standard of care technique to access the right jugular vein. Thru an introducer the Sync-AV II Temporary Cardiac Pacing Catheter is inserted Confirm and document the leads location as a baseline reference.
Acute Pacing Evaluation Acute pacing threshold evaluation will be performed immediate after leads deployed and at the end of the concomitant procedure.
Pacing Support During Concomitant Procedure Pacing setting to support for subject's medical need during concomitant procedure is per investigator's discretion.
Pacing Support During Hospital Stay Pacing setting to support for subject's medical need during hospital stay is per investigator's discretion.
Pacing Evaluation prior to Lead Removal Pacing lead evaluation will be performed immediately prior to the pacing catheter removal. The evaluation protocol will be the same as the lead evaluation at 24 hours post implant.
End of Study Subjects will exit the study after 7 days follow-up post procedure.
- Conditions
- Heart Block, Valve Heart Disease
- Being tested
- Temporary pacing
- Medical subject headings
- Heart Block, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary pacingDevice
Transvenous temporary cardiac pacing - right internal jugular insertion
What is being measured
The primary outcome is the main question the study is designed to answer.
With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)
Number of participants with a mean ventricular pacing threshold of less than 2.1 volts, measured at 24 hours post index procedure.
Measured: 24 hours post implant
Procedure related complications
Incidence of serious procedural related complications
The procedure-related serious complication is defined as:
- Device-related endocarditis
- Clinically significant cardiac perforation
- New pericardial effusions requiring intervention
- Sustained ventricular or atrial arrhythmia
- Cardiac tamponade
- Bleeding requiring transfusion
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jun 2023
- Primary completion13 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart BlockStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swift Sync, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Quality Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261788
- Sponsor's protocol ID
- EASY II Trial
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be determined by board of directors at a later time
Publications
Tancredi RG, McCallister BD, Mankin HT. Temporary transvenous catheter-electrode pacing of the heart. Circulation. 1967 Oct;36(4):598-608. doi: 10.1161/01.cir.36.4.598. No abstract available.
PubMed 6041872Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.
PubMed 9545357Perez SA, Ebner B, Kall CMY, Mitrani R, de Marchena EJ. A novel temporary atrioventricular sequential pacing catheter-Characteristics and first-in-human application. J Card Surg. 2022 Oct;37(10):2991-2996. doi: 10.1111/jocs.16796. Epub 2022 Jul 28.
PubMed 35900290
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)
- ClinicalTrials.gov ID
- NCT06261788
- Acronym / sponsor ID
- EASY II Trial
- Conditions
- Heart Block, Valve Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swift Sync, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Quality Solutions
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 15 Feb 2024 (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 is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support.
Detailed description
The study will enroll up to 31 subjects at one investigational site with at least 3 implanters.
The subjects enrolled will be followed 7 days after the Sync-AV II Temporary Cardiac Pacing Catheter is removed. A safety call or clinic visit at 7 days post discharge will be performed.
Only subjects who meet the inclusion/exclusion criteria and provide informed consent will be eligible to receive the treatment and participate in the study. potential subjects who have a surgical or interventional procedure that will require temporary cardiac pacing support for at least 24 hours per investigator's medical judgement.
The elective surgical or interventional procedure is to be performed per institutional standard of care. Other concomitant therapy (medication and non-medication therapies) may be used during the study for the treatment or prevention of disease or to maintain good health.
Study Procedure standard of care technique to access the right jugular vein. Thru an introducer the Sync-AV II Temporary Cardiac Pacing Catheter is inserted Confirm and document the leads location as a baseline reference.
Acute Pacing Evaluation Acute pacing threshold evaluation will be performed immediate after leads deployed and at the end of the concomitant procedure.
Pacing Support During Concomitant Procedure Pacing setting to support for subject's medical need during concomitant procedure is per investigator's discretion.
Pacing Support During Hospital Stay Pacing setting to support for subject's medical need during hospital stay is per investigator's discretion.
Pacing Evaluation prior to Lead Removal Pacing lead evaluation will be performed immediately prior to the pacing catheter removal. The evaluation protocol will be the same as the lead evaluation at 24 hours post implant.
End of Study Subjects will exit the study after 7 days follow-up post procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is undergoing a surgical or an interventional procedure requiring temporary cardiac pacing to support for at least 24 hours per investigator's medical judgement.
- Subject is at least 18 years of age.
- Subject or legal representative provides written informed consent to the study.
Key exclusion criteria (13 listed)
- Subject has a co-exist temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator.
- Subject on cardiogenic shock.
- Subject is currently in atrial fibrillation.
- Subject is pregnant or breastfeeding.
- Subject had a stroke within 6 months prior to enrollment.
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 |
|---|---|---|
| Temporary pacingTransvenous temporary cardiac pacing - right internal jugular insertion | Device | – |
Primary outcome
With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)
Time frame: 24 hours post implant
Number of participants with a mean ventricular pacing threshold of less than 2.1 volts, measured at 24 hours post index procedure.
Procedure related complications
Time frame: through study completion, an average of 7 days
Incidence of serious procedural related complications The procedure-related serious complication is defined as: * Device-related endocarditis * Clinically significant cardiac perforation * New pericardial effusions requiring intervention * Sustained ventricular or atrial arrhythmia * Cardiac tamponade * Bleeding requiring transfusion
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 15 Feb 2024.
- Background: PubMed 6041872Tancredi RG, McCallister BD, Mankin HT. Temporary transvenous catheter-electrode pacing of the heart. Circulation. 1967 Oct;36(4):598-608. doi: 10.1161/01.cir.36.4.598. No abstract available.
- Background: PubMed 9545357Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.
- Background: PubMed 35900290Perez SA, Ebner B, Kall CMY, Mitrani R, de Marchena EJ. A novel temporary atrioventricular sequential pacing catheter-Characteristics and first-in-human application. J Card Surg. 2022 Oct;37(10):2991-2996. doi: 10.1111/jocs.16796. Epub 2022 Jul 28.
- Individual participant dataSharing planned: Undecided. will be determined by board of directors at a later time
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary pacing in people with Heart Block and Valve Heart Disease, run by Swift Sync, Inc. at 1 site in Paraguay.
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 13 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 15 Feb 2024. 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 Paraguay. 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?
With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure) (time frame: 24 hours post implant). 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 NCT06261788, which also lists 3 linked publications.
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 15 Feb 2024.