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The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythmia HDx and DirectSense technology | Other | Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation procedure | Device | Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system. | Day 0 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0). *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system. |
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Inclusion Criteria:
• History of recurrent symptomatic PAF with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
Exclusion Criteria:
• Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment:
New York Heart Association (NYHA) Class III or IV
Left ventricular ejection fraction (LVEF) <35%
Left atrial (LA) diameter >5.5 cm
Unstable angina or ongoing myocardial ischemia (OMI)
Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Garcia Bolao, MD | Clinica Universitaria de Navarra | Principal Investigator |
| Bruno Reissmann, MD | Universitäres Herzzentrum Hamburg | Principal Investigator |
| Armin Luik, MD | Stadtisches Klinikum Karlsruhe | Principal Investigator |
| Pierre Jais, MD | University Hospital, Bordeaux | Principal Investigator |
| Moloy Das, MD | Freeman Health System | Principal Investigator |
| Waqas Ullah, MD | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| Universitäres Herzzentrum Hamburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35589172 | Derived | Garcia-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23. |
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No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
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| ID | Title | Description |
|---|---|---|
| FG000 | Rhythmia HDx and DirectSense Technology | Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 |
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| Day 0 |
| Number of Gaps at Day Zero | At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair. | Day 0 |
| Baseline Local Impedance and Local Impedance Change at Day Zero | Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period. | Day 0 |
| Maximum Number of Gaps Per PV Segment at Day Zero | At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair. | Day 0 |
| Local Impedance in Segments With Maximum Number of Gaps at Day Zero | Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps | Day 0 |
| Hamburg |
| Germany |
| Stadtisches Klinikum Karlsruhe | Karlsruhe | Germany |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| Freeman Hospital | Newcastle | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rhythmia HDx and DirectSense Technology | Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Mean | Standard Deviation | cm |
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| Weight | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Mean | Standard Deviation | kg |
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| Resting Heart Rate | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Mean | Standard Deviation | bpm |
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| Systolic Blood pressure | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | 62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline. For one additional subject the data was not collected | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure. *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system. | 51 subjects were included in the analysis as 7 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis. | Posted | Median | Inter-Quartile Range | ohm | Day 0 and 3 months | Overall number of Ablations | Overall number of Ablations |
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| Secondary | Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0). *Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system. | 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis. | Posted | Median | Inter-Quartile Range | ohm | Day 0 | Overall number of Ablations | Overall number of Ablations |
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| Secondary | Number of Gaps at Day Zero | At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair. | Posted | Mean | Standard Deviation | Number of gaps | Day 0 |
|
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| Secondary | Baseline Local Impedance and Local Impedance Change at Day Zero | Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period. | 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis. | Posted | Mean | Standard Deviation | ohm | Day 0 | Overall number of Ablations | Overall number of Ablations |
| |||||||||||||||||||||||||||||||||||
| Secondary | Maximum Number of Gaps Per PV Segment at Day Zero | At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair. | Posted | Number | Number of gaps | Day 0 |
|
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| Secondary | Local Impedance in Segments With Maximum Number of Gaps at Day Zero | Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps | 55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis. | Posted | Mean | Standard Deviation | ohm | Day 0 | Overall number of Ablations | Overall number of Ablations |
|
Adverse events were collected from enrollment to end of follow-up: 4 Months.
Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rhythmia HDx and DirectSense Technology | Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter. Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter. Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI. | 0 | 62 | 8 | 62 | 4 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Systematic Assessment |
| ||
| Adverse reaction - Neurological (non-TIA, non-stroke) | Surgical and medical procedures | Systematic Assessment | Unresponsiveness and Acute Confusion |
| |
| Stroke (ischemic) | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pain in the lower stomach, ague, ascites, pleural effusion |
| |
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment | Slow sinus rhythm leading to dizziness |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoptosis | Surgical and medical procedures | Systematic Assessment |
| ||
| Left Atrial (type II) Flutter | Surgical and medical procedures | Systematic Assessment | Atypical Flutter |
| |
| NSVT (Non Sustained Ventricular Tachycardia) | Surgical and medical procedures | Systematic Assessment |
| ||
| Pseudoaneurysm | Surgical and medical procedures | Systematic Assessment | Radial Artery Pseudoaneurysm |
| |
| Visual blurring/disturbances | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Flutter, not specified | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Boston Scientific | 00393421994999 | alberto.belligoli@bsci.com |
| Jun 11, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Germany |
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| Spain |
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| Local Impedance change in Pulmonary Veins segments where block was not achieved |
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| Overall number of Ablations |
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