Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
Conditions
Brief summary
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation
Detailed description
This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.
Interventions
DEVICERenal Artery Ablation
Renal artery denervation using the EnligHTN™ Renal Denervation System
DEVICECardiac Ablation
Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age at time of consent * Subject must be able and willing to provide written informed consent * Subject must be able and willing to comply with the required follow-up schedule * Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care * Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit * Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg within 90 days prior to procedure * Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking \>3 anti-hypertensive medications, including 1 diuretic * Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure
Exclusion criteria
* Subject has long standing atrial fibrillation * Subject has had a previous ablation for atrial fibrillation * Subject has had a previous renal denervation procedure * Subject has had a CABG procedure within the last 180 days (six months) * Subject has a left atrial thrombus * Subject has a contraindication to anticoagulation (i.e. heparin or warfarin) * Subject has unstable angina * Subject has had a myocardial infarction within the previous two months * Subject has a left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure TTE * Subject has significant renovascular abnormalities such as renal artery stenosis \> 30% * Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts * Subject has hemodynamically significant valvular heart disease as determined by study investigator * Subject has a life expectancy less than 12 months, as determined by the study investigator * Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic) * Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods * Subject has active systemic infection * Subject has renal arteries \< 4 mm in diameter * Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula * Subject had a renal transplant or is awaiting a renal transplant * Subject has blood clotting or bleeding abnormalities * Subject has secondary arterial hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Atrial Fibrillation at 12 Month | 12 months | The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience Peri-procedural Events | 30 days post procedure | Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22) |
| Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | 6 months and 12 months post procedure | Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22). |
| Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months | Baseline and 6 months | — |
| Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months | Baseline and 12 months | — |
| Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | 3 months, 6 months, 12 months, 24 months | Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20) |
| Major Adverse Cardiac Events (MACE) | 7 days, 6 months, 12 months, and 24 months post procedure | Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22). |
| Change in Ambulatory Blood Pressure at 12 Months | Baseline and 12 months post procedure | Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14) |
| Change in Ambulatory Blood Pressure at 24 Months | Baseline and 24 months post procedure | Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12) |
| Change in Office Blood Pressure at 12 Months | Baseline and 12 months post procedure | Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15) |
| Change in Office Blood Pressure at 24 Months | Baseline and 24 months post procedure | Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16). |
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg | 6 months post procedure | — |
Countries
Germany
Participant flow
Recruitment details
Study enrollment was completed with a total of 61 participants randomized at 2 sites in Germany. The first and last participants were enrolled on May 12, 2014, and July 21, 2016, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation. | 39 |
| Cardiac Ablation (AF) Participants treated with cardiac ablation alone. | 22 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criteria not met | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Participant met exclusion criteria | 0 | 1 |
| Overall Study | Participant refused 24-month follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Total | Cardiac Ablation (AF) | Renal Artery Ablation + Cardiac Ablation (RDN+AF) |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 8.7 | 63.0 years STANDARD_DEVIATION 9.9 | 66.3 years STANDARD_DEVIATION 7.9 |
| Body mass Index (BMI) | 31.6 kg/m^2 STANDARD_DEVIATION 5.1 | 31.0 kg/m^2 STANDARD_DEVIATION 5.4 | 31.9 kg/m^2 STANDARD_DEVIATION 5 |
| Height | 173.0 cm STANDARD_DEVIATION 9.8 | 173.6 cm STANDARD_DEVIATION 9.4 | 172.7 cm STANDARD_DEVIATION 10.1 |
| Medical History Arrhythmia | 61 Participants | 22 Participants | 39 Participants |
| Medical History Cardiomyopathy | 3 Participants | 1 Participants | 2 Participants |
| Medical History Coronary Artery Disease | 12 Participants | 7 Participants | 5 Participants |
| Medical History Diabetes | 23 Participants | 7 Participants | 16 Participants |
| Medical History Hyperlipidemia | 31 Participants | 11 Participants | 20 Participants |
| Medical History Liver Disease | 6 Participants | 4 Participants | 2 Participants |
| Medical History Myocardial Infarction | 4 Participants | 3 Participants | 1 Participants |
| Medical History Neurological events/Dysfunction | 4 Participants | 2 Participants | 2 Participants |
| Medical History Obstructive Sleep Apnea | 4 Participants | 1 Participants | 3 Participants |
| Medical History Other Additional Medical History | 56 Participants | 18 Participants | 38 Participants |
| Medical History Significant Alcohol Intake | 6 Participants | 0 Participants | 6 Participants |
| Medical History Smokers | 21 Participants | 4 Participants | 17 Participants |
| Medical History Thyroid Disease | 14 Participants | 6 Participants | 8 Participants |
| Medical History Valvular Disease | 42 Participants | 15 Participants | 27 Participants |
| New York Heart Association (NYHA) Class of Cardiac Disease Class I | 21 Participants | 11 Participants | 10 Participants |
| New York Heart Association (NYHA) Class of Cardiac Disease Class II | 34 Participants | 10 Participants | 24 Participants |
| New York Heart Association (NYHA) Class of Cardiac Disease Class III | 6 Participants | 1 Participants | 5 Participants |
| New York Heart Association (NYHA) Class of Cardiac Disease Class IV | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with a history of renal assessment prior to enrollment | 2 Participants | 0 Participants | 2 Participants |
| Office Blood Pressure Office Diastolic Blood Pressure | 88.9 mmHg STANDARD_DEVIATION 13 | 91.4 mmHg STANDARD_DEVIATION 10.6 | 87.5 mmHg STANDARD_DEVIATION 14.1 |
| Office Blood Pressure Office Systolic Blood Pressure | 163.9 mmHg STANDARD_DEVIATION 18.5 | 167.1 mmHg STANDARD_DEVIATION 18.5 | 162.0 mmHg STANDARD_DEVIATION 18.6 |
| Office Heart Rate | 79.7 beats per minute (bpm) STANDARD_DEVIATION 22.4 | 76.7 beats per minute (bpm) STANDARD_DEVIATION 19.5 | 81.3 beats per minute (bpm) STANDARD_DEVIATION 23.9 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Germany | 61 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Female | 29 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 32 Participants | 12 Participants | 20 Participants |
| Weight | 94.8 kg STANDARD_DEVIATION 18.2 | 93.7 kg STANDARD_DEVIATION 19.1 | 95.4 kg STANDARD_DEVIATION 17.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 22 |
| other Total, other adverse events | 4 / 39 | 2 / 22 |
| serious Total, serious adverse events | 4 / 39 | 3 / 22 |
Outcome results
Primary
Number of Participants With Freedom From Atrial Fibrillation at 12 Month
The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).
Time frame: 12 months
Population: Data not collected from all participants: data were available for only 28 participants in the RDN+AF group, and 12 participants in the AF group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Number of Participants With Freedom From Atrial Fibrillation at 12 Month | 16 Participants |
| Cardiac Ablation (AF) | Number of Participants With Freedom From Atrial Fibrillation at 12 Month | 4 Participants |
Comparison: Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.p-value: 0.22Log Rank
Secondary
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Time frame: 6 months and 12 months post procedure
Population: Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | VASC Pseudoaneurysm at 6 months | 1 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | VASC Pseudoaneurysm at 12 months | 2 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | Renal Artery Stenosis at 6 months | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | Renal Artery Stenosis at 12 months | 1 Participants |
| Cardiac Ablation (AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | Renal Artery Stenosis at 12 months | 0 Participants |
| Cardiac Ablation (AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | VASC Pseudoaneurysm at 6 months | 0 Participants |
| Cardiac Ablation (AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | Renal Artery Stenosis at 6 months | 0 Participants |
| Cardiac Ablation (AF) | Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation | VASC Pseudoaneurysm at 12 months | 0 Participants |
Secondary
Change in Ambulatory Blood Pressure at 12 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Time frame: Baseline and 12 months post procedure
Population: Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Ambulatory Blood Pressure at 12 Months | 24-Hour Ambulatory Systolic Blood Pressure (ASBP) | -5.9 mmHg | Standard Deviation 15.2 |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Ambulatory Blood Pressure at 12 Months | 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) | -5.8 mmHg | Standard Deviation 7.4 |
| Cardiac Ablation (AF) | Change in Ambulatory Blood Pressure at 12 Months | 24-Hour Ambulatory Systolic Blood Pressure (ASBP) | -3.1 mmHg | Standard Deviation 19.2 |
| Cardiac Ablation (AF) | Change in Ambulatory Blood Pressure at 12 Months | 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) | -8.4 mmHg | Standard Deviation 9.4 |
Comparison: Change in ASBP at 12 monthsp-value: 0.084995% CI: [-12.61, 0.88]Paired Student's t-test
Comparison: Change in ADBP at 12 monthsp-value: 0.001495% CI: [-9.12, -2.52]Paired Student's t-test
Comparison: Change in ASBP at 12 months.p-value: 0.559995% CI: [-14.16, 8.02]Paired Student's t-test
Comparison: Change in ADBP at 12 monthsp-value: 0.005295% CI: [-13.87, -2.99]Paired Student's t-test
Secondary
Change in Ambulatory Blood Pressure at 24 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
Time frame: Baseline and 24 months post procedure
Population: Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Ambulatory Blood Pressure at 24 Months | 24-Hour Ambulatory Systolic Blood Pressure (ASBP) | -5.7 mmHg | Standard Deviation 14.8 |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Ambulatory Blood Pressure at 24 Months | 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) | -6.9 mmHg | Standard Deviation 6.1 |
| Cardiac Ablation (AF) | Change in Ambulatory Blood Pressure at 24 Months | 24-Hour Ambulatory Systolic Blood Pressure (ASBP) | -8.6 mmHg | Standard Deviation 12.4 |
| Cardiac Ablation (AF) | Change in Ambulatory Blood Pressure at 24 Months | 24-Hour Ambulatory Diastolic Blood Pressure (ADBP) | -10.3 mmHg | Standard Deviation 8.5 |
Comparison: Change in ASBP at 24 monthsp-value: 0.132695% CI: [-13.34, 1.93]Paired Student's t-test
Comparison: Change in ADBP at 24 monthsp-value: 0.000295% CI: [-10.06, -3.83]Paired Student's t-test
Comparison: Change in ASBP at 24 monthsp-value: 0.035495% CI: [-16.47, -0.7]Paired Student's t-test
Comparison: Change in ADBP at 24 monthsp-value: 0.001595% CI: [-15.75, -4.91]Paired Student's t-test
Secondary
Change in Office Blood Pressure at 12 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Time frame: Baseline and 12 months post procedure
Population: Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Office Blood Pressure at 12 Months | Change in Office Systolic Blood Pressure (OSBP) | 2.6 mmHg | Standard Deviation 24.4 |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Office Blood Pressure at 12 Months | Change in Office Diastolic Blood Pressure (ODBP) | -0.4 mmHg | Standard Deviation 11.8 |
| Cardiac Ablation (AF) | Change in Office Blood Pressure at 12 Months | Change in Office Systolic Blood Pressure (OSBP) | 2.0 mmHg | Standard Deviation 30 |
| Cardiac Ablation (AF) | Change in Office Blood Pressure at 12 Months | Change in Office Diastolic Blood Pressure (ODBP) | -5.4 mmHg | Standard Deviation 15.8 |
Comparison: Change in OSBP at 12 months.p-value: 0.539995% CI: [-6, 11.3]Paired Student's t-test
Comparison: Change in Office Diastolic Blood Pressure (ODBP) at 12 monthsp-value: 0.848995% CI: [-4.6, 3.8]Paired Student's t-test
p-value: 0.799995% CI: [-14.6, 18.6]Paired Student's t-test
Comparison: Change in ODBP at 12 monthsp-value: 0.207695% CI: [-14.2, 3.4]Paired Student's t-test
Secondary
Change in Office Blood Pressure at 24 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Time frame: Baseline and 24 months post procedure
Population: Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Office Blood Pressure at 24 Months | Change in Office Systolic Blood Pressure (OSBP) | 0.6 mmHg | Standard Deviation 22.3 |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Change in Office Blood Pressure at 24 Months | Change in Office Diastolic Blood Pressure (ODBP) | 0.5 mmHg | Standard Deviation 11 |
| Cardiac Ablation (AF) | Change in Office Blood Pressure at 24 Months | Change in Office Systolic Blood Pressure (OSBP) | 7.4 mmHg | Standard Deviation 22.9 |
| Cardiac Ablation (AF) | Change in Office Blood Pressure at 24 Months | Change in Office Diastolic Blood Pressure (ODBP) | -3.0 mmHg | Standard Deviation 15.5 |
Comparison: Change in OSBP at 24 monthsp-value: 0.88295% CI: [-7.9, 9.1]Paired Student's t-test
Comparison: Change in ODBP at 24 monthsp-value: 0.801995% CI: [-3.7, 4.7]Paired Student's t-test
Comparison: Change in OSBP at 24 monthsp-value: 0.217795% CI: [-4.8, 19.6]Paired Student's t-test
Comparison: Change in ODBP at 24 monthsp-value: 0.450295% CI: [-11.2, 5.2]Paired Student's t-test
Secondary
Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).
Time frame: 7 days, 6 months, 12 months, and 24 months post procedure
Population: For each group, the outcome measure was analyzed in participants randomized at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Major Adverse Cardiac Events (MACE) | MACE within 7 days of procedure | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Major Adverse Cardiac Events (MACE) | MACE within 6 months of procedure | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Major Adverse Cardiac Events (MACE) | MACE within 12 months of procedure | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Major Adverse Cardiac Events (MACE) | MACE within 24 months of procedure | 0 Participants |
| Cardiac Ablation (AF) | Major Adverse Cardiac Events (MACE) | MACE within 24 months of procedure | 2 Participants |
| Cardiac Ablation (AF) | Major Adverse Cardiac Events (MACE) | MACE within 7 days of procedure | 2 Participants |
| Cardiac Ablation (AF) | Major Adverse Cardiac Events (MACE) | MACE within 12 months of procedure | 2 Participants |
| Cardiac Ablation (AF) | Major Adverse Cardiac Events (MACE) | MACE within 6 months of procedure | 2 Participants |
Secondary
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
Time frame: 6 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg | 4 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg | 1 Participants |
Secondary
Percentage of Participants Who Experience Peri-procedural Events
Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22)
Time frame: 30 days post procedure
Population: Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Cardiac Arrest | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Pericardial Effusion | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Paroxysmal Atrial Tachycardia | 1 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Hematoma | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Pericardial Tamponade | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Bleeding | 0 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | VASC Pseudoaneurysm | 1 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Air Embolus | 3 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Paroxysmal Atrial Fibrillation | 1 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Percentage of Participants Who Experience Peri-procedural Events | Vasospasm | 1 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Air Embolus | 0 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Cardiac Arrest | 1 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Bleeding | 1 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Pericardial Effusion | 1 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Vasospasm | 0 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Paroxysmal Atrial Tachycardia | 0 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | VASC Pseudoaneurysm | 0 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Hematoma | 1 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Paroxysmal Atrial Fibrillation | 0 Participants |
| Cardiac Ablation (AF) | Percentage of Participants Who Experience Peri-procedural Events | Pericardial Tamponade | 1 Participants |
Secondary
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20)
Time frame: 3 months, 6 months, 12 months, 24 months
Population: For each group, the outcome measure was analyzed in participants who underwent the procedure (RDN+AF group= 39, AF group=20)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 3 months | 4 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 6 months | 9 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 12 months | 14 Participants |
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 24 months | 19 Participants |
| Cardiac Ablation (AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 24 months | 9 Participants |
| Cardiac Ablation (AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 3 months | 4 Participants |
| Cardiac Ablation (AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 12 months | 8 Participants |
| Cardiac Ablation (AF) | Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure. | Atrial Fibrillation recurrence within 6 months | 5 Participants |
Secondary
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
Time frame: Baseline and 12 months
Population: eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 33)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months | -0.4 mL/min per 1.73m^2 | Standard Deviation 11.9 |
p-value: 0.7663Wilcoxon signed-rank test
Secondary
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
Time frame: Baseline and 6 months
Population: eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 32)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Artery Ablation + Cardiac Ablation (RDN+AF) | Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months | 2.2 mL/min per 1.73m^2 | Standard Deviation 11 |
p-value: 0.2766Paired Student's t-test