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出境医 / 临床实验 / HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System
HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System
Study Description
Brief Summary:
The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.
| Condition or disease |
|---|
| HBP |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | HBP Synchrony Using ECG Belt |
| Actual Study Start Date : | June 1, 2021 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | May 1, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Characterize the electrical dispersion using SDAT [ Time Frame: 1 year ]Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction.
Criteria
Inclusion Criteria:
- Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead
- Patient has intrinsic AV conduction
- Normal EF, defined as EF >50%, as shown on recent echo within last 12 months
- Patient is willing and able to comply with the protocol
- Patient is 18 years of age or older
Exclusion Criteria:
●Patient is ventricular pacer dependent
Contacts and Locations
Locations
| United States, Florida | |
| Orlando Cardiac & Vascular Specialists | Recruiting |
| Altamonte Springs, Florida, United States, 32701 | |
| Contact: Sambit Mondal, MD 407-915-5643 sambitmondal@gmail.com | |
Sponsors and Collaborators
SAMBIT MONDAL
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | June 11, 2021 | ||
| First Posted Date | June 18, 2021 | ||
| Last Update Posted Date | June 18, 2021 | ||
| Actual Study Start Date | June 1, 2021 | ||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Characterize the electrical dispersion using SDAT [ Time Frame: 1 year ] Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system.
|
||
| Original Primary Outcome Measures | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System | ||
| Official Title | HBP Synchrony Using ECG Belt | ||
| Brief Summary | The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing. | ||
| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction. | ||
| Condition | HBP | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
| Recruitment Information | |||
| Recruitment Status | Recruiting | ||
| Estimated Enrollment |
30 | ||
| Original Estimated Enrollment | Same as current | ||
| Estimated Study Completion Date | May 1, 2022 | ||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: ●Patient is ventricular pacer dependent |
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | Not Provided | ||
| Contacts | |||
| Listed Location Countries | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT04930601 | ||
| Other Study ID Numbers | OSCMondal062021 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | SAMBIT MONDAL, Orlando Cardiac and Vascular Specialists | ||
| Study Sponsor | SAMBIT MONDAL | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Orlando Cardiac and Vascular Specialists | ||
| Verification Date | June 2021 | ||