Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DEVICEAblation procedure
Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. * Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD); * Eligible for an ablation procedure with the Rhythmia HDx mapping system (software version 2.0 or any future commercially available Software Version), IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter according to current international and local guidelines (and future revisions) and per physician discretion; * Subjects who are willing and capable of providing informed consent; * Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center; * Age 18 to 80
Exclusion criteria
* • Diagnosed with any of the following heart conditions within 90 days (3 months) prior to enrollment: 1. New York Heart Association (NYHA) Class III or IV 2. Left ventricular ejection fraction (LVEF) \<35% 3. Left atrial (LA) diameter \>5.5 cm 4. Unstable angina or ongoing myocardial ischemia (OMI) 5. Transmural myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery * Active systemic infection or sepsis; * Undergone any left atrial heart ablation procedure, either surgical or catheter ablation * Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route * Subject has a Left Atrial Appendage Closure (LAAC) or Percutaneous Transcatheter Closure of a Patent Foramen Ovale (PFO) * Subject has persistent or long-standing persistent atrial fibrillation (AF) ( \>1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year) * Life expectancy ≤ 6 months per physician judgment * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility; * The subject is unable or not willing to complete follow-up visits and examination for the duration of the study; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Day 0 and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Day 0 | 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. |
| Number of Gaps at Day Zero | Day 0 | 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. |
| Baseline Local Impedance and Local Impedance Change at Day Zero | Day 0 | 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. |
| Maximum Number of Gaps Per PV Segment at Day Zero | Day 0 | 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. |
| Local Impedance in Segments With Maximum Number of Gaps at Day Zero | Day 0 | 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 |
Countries
France, Germany, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Rhythmia HDx and DirectSense Technology | — |
|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11 | — |
| Diastolic Blood Pressure | 72 mmHg STANDARD_DEVIATION 9 | — |
| Height | 172 cm STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 1 participants | — |
| Region of Enrollment Germany | 12 participants | — |
| Region of Enrollment Spain | 30 participants | — |
| Region of Enrollment United Kingdom | 19 participants | — |
| Resting Heart Rate | 66 bpm STANDARD_DEVIATION 15 | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 33 Participants | — |
| Systolic Blood pressure | 126 mmHg STANDARD_DEVIATION 16 | — |
| Weight | 80 kg STANDARD_DEVIATION 12 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 4 / 62 |
| serious Total, serious adverse events | 8 / 62 |
Outcome results
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.
Time frame: Day 0 and 3 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Local Impedance change in Pulmonary Veins segments where block was achieved | -19.6 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved | 101.9 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Local Impedance change in Pulmonary Veins segments where block was not achieved | -13.9 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment | Local Impedance at Baseline in Pulmonary Veins segments where block was achieved | 106.2 ohm |
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.
Time frame: Day 0
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Baseline Local Impedance and Local Impedance Change at Day Zero | Baseline Local Impedance during initial applications | 107.9 ohm | Standard Deviation 15.9 |
| Rhythmia HDx and DirectSense Technology | Baseline Local Impedance and Local Impedance Change at Day Zero | Baseline Local Impedance during touch up applications | 96.1 ohm | Standard Deviation 13 |
| Rhythmia HDx and DirectSense Technology | Baseline Local Impedance and Local Impedance Change at Day Zero | Local Impedance change during initial applications | -19.8 ohm | Standard Deviation 11.1 |
| Rhythmia HDx and DirectSense Technology | Baseline Local Impedance and Local Impedance Change at Day Zero | Local Impedance change during touch up applications | -20.2 ohm | Standard Deviation 9.5 |
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.
Time frame: Day 0
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved | 101.1 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Local Impedance at Baseline in Pulmonary Veins segments where block was achieved | 107 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Local Impedance change in Pulmonary Veins segments where block was achieved | -19.4 ohm |
| Rhythmia HDx and DirectSense Technology | Local Impedance and Local Impedance Change and PVI Gaps at Day Zero | Local Impedance change in Pulmonary Veins segments where block was not achieved | -10.9 ohm |
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
Time frame: Day 0
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Local Impedance in Segments With Maximum Number of Gaps at Day Zero | Average baseline local impedance in left PV segment with maximum gaps = along appendage/LA ridge | 105.2 ohm | Standard Deviation 13.5 |
| Rhythmia HDx and DirectSense Technology | Local Impedance in Segments With Maximum Number of Gaps at Day Zero | Average baseline local impedance in right PV segment with maximum gaps = near LA roof | 105.1 ohm | Standard Deviation 14.3 |
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.
Time frame: Day 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Maximum Number of Gaps Per PV Segment at Day Zero | Maximum # of gaps observed in a left PV pair segment at index procedure = along appendage/LA ridge | 25 Number of gaps |
| Rhythmia HDx and DirectSense Technology | Maximum Number of Gaps Per PV Segment at Day Zero | Maximum # of gaps observed in a right PV pair segment at index procedure = near LA roof | 18 Number of gaps |
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.
Time frame: Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rhythmia HDx and DirectSense Technology | Number of Gaps at Day Zero | Number of gaps per Left PV pair after initial encircling | 1.4 Number of gaps | Standard Deviation 1.6 |
| Rhythmia HDx and DirectSense Technology | Number of Gaps at Day Zero | Number of gaps per Right PV pair after initial encircling | 1.5 Number of gaps | Standard Deviation 1.6 |