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The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation only | Active Comparator | Pulmonary vein isolation |
|
| Cryoablation and renal nerve denervation | Experimental | Pulmonary vein isolation plus renal nerve denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter | Device |
| ||
| Arctic Front Advance™ Cardiac Cryoablation System |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects in Each Arm That Experience Safety Composite Events | Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure. | Up to one or six months post procedure depending on the event |
| Proportion of Patients With Chronic Treatment Success | Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF. | Minimum of six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline | Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms. | 6 months |
| Difference in Heart Rate at 6 Months and Baseline |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Chinitz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Medical Group-Cardiology | Sacramento | California | 95819 | United States | ||
| Lahey Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34269911 | Derived | Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4. |
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28 subjects were exited prior to randomization for not meeting study eligibility criteria. Of the 74 randomized subjects, 3 in the PVI+RDN group were not treated and 1 in the Control group (PVI only) were not treated.
The first subject was enrolled on February 6, 2015 and the last subject was enrolled on September 9, 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation Only | Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System |
| FG001 | Cryoablation and Renal Nerve Denervation | Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System |
| 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 | Yes | No | No | Study Protocol | Aug 19, 2020 | Dec 13, 2023 |
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| Device |
|
Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms. |
| 6 months |
| Procedural Measures | Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group. | Procedure |
| Proportion of Participants With Symptoms at 6 Months Between Study Arms | The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit:
| 6 months |
| Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period. | Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period. | 6 months |
| Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period | Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms. | 91 days after the cryoablation procedure date until the last Reveal LINQ device data date. |
| Burlington |
| Massachusetts |
| 01805 |
| United States |
| UPHS-Marquette | Marquette | Michigan | 49855 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Swedish Medical Center Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation Only | Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System |
| BG001 | Cryoablation and Renal Nerve Denervation | Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Proportion of Subjects in Each Arm That Experience Safety Composite Events | Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure. | Posted | Count of Participants | Participants | Up to one or six months post procedure depending on the event |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Patients With Chronic Treatment Success | Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF. | Posted | Count of Participants | Participants | Minimum of six months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline | Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Difference in Heart Rate at 6 Months and Baseline | Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms. | Posted | Mean | Standard Deviation | beats per minute | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Procedural Measures | Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group. | The analysis population for Renal Denervation Procedure and Total Procedure Time does not include participants from the Cryoablation only group since they did not receive the Renal Artery Denervation Procedure. | Posted | Mean | Standard Deviation | minutes | Procedure |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Symptoms at 6 Months Between Study Arms | The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit:
| Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period. | Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period. | If a subject has not used Class I or III anti-arrhythmic drugs at all following the blanking period, all of their follow-up will be used for this analysis. If a subject has used either Class I or Class III anti-arrhythmic drugs after the blanking period, they will be excluded for this analysis. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period | Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms. | Posted | Mean | Standard Deviation | Percent of time | 91 days after the cryoablation procedure date until the last Reveal LINQ device data date. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Daily Atrial Arrhythmia Burden From Baseline to End of ILR Recording for Patients Who Had a Mean Burden of Greater Than or Equal to 1 Hour Per Day on the Days They Experienced Atrial Arrhythmia(s) | Calculate the daily atrial arrhythmia burden in hours from baseline to end of the ILR recording. The patients who had a mean burden of 1 or more hours per day on the days they experienced atrial arrhythmias are included in the analysis. From these patients, it is then determined the mean daily atrial arrhythmia burden between groups. | Posted | Mean | Standard Deviation | hours | Baseline till end of recording of implantable loop recorder |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Patients Who Discontinued Class I/III Anti-arrhythmic Drugs | Compare the number of patients who discontinued Class I/III anti-arrhythmic drugs between groups | Posted | Count of Participants | Participants | Baseline till end of follow-up (varies per patient) |
|
|
From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit.
Adverse event that:
led to death
led to serious deterioration in health of the subject, that resulted in
b) led to fetal distress, fetal death or congenital abnormality or birth defect
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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 | Cryoablation Only | Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System | 1 | 36 | 17 | 36 | 22 | 36 |
| EG001 | Cryoablation and Renal Nerve Denervation | Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System | 0 | 34 | 20 | 34 | 24 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Puncture site hematoma | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| CHA2DS2-VASc annual stroke risk moderate | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastric mucosa erythema | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Incision site oedema | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Phrenic nerve injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa DeBruin | Medtronic, Inc. | 6123607687 | vanessa.debruin@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2018 | Dec 13, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Male |
|
| Subject/Physician Chose Not to Provide Information |
|
| White |
|
| Black or African American |
|
| Asian |
|
| Hispanic or Latino |
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| Other |
|
| Germany |
|
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