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The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.
The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analysis Population | Experimental | The analysis population will include patients considered at high or extreme surgical risk, who have met all inclusion criteria, have not met any exclusion criteria, have signed an Ethics Committee (EC) approved Informed Consent, and, at the minimum, the FlexNav delivery system entered his/her vasculature for an attempted Portico or Navitor Valve implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Device | Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| Myocardial Infarction Rate | Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure | 30 days post index procedure |
| VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barathi Sethuraman | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apollo Hospital | Chennai | India | ||||
| Medanta-The Medicity |
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| ID | Title | Description |
|---|---|---|
| FG000 | Portico Valve | Patients implanted with Portico Valve |
| FG001 | Navitor Valve | Patients implanted with Navitor Valve |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Portico Valve | Patients implanted with Portico Valve |
| BG001 | Navitor Valve | Patients implanted with Navitor Valve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
9 months
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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 | Portico Valve | Patients implanted with Portico Valve | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karine Miquel | Abbott | +32 479 600 107 | karine.miquel@abbott.com |
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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 | Dec 28, 2022 | Mar 30, 2026 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| 30 days post index procedure |
| VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 30 days post index procedure |
| Percentage of Subjects With Implant Success | Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery | During procedure |
| Echocardiographic Assessment of the Mean Aortic Gradient | Units=mmHg | 30 days post index procedure |
| Echocardiographic Assessment of Effective Orifice Area (EOA) | units = cm2 | 30 days post index procedure |
| Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days. | Reported as either none/trace, mild, moderate, or severe | 30 days post index procedure |
| VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 9 months post index procedure |
| VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | 9 months post index procedure |
| New York Heart Association (NYHA) Functional Class | Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV. | 30 days post index procedure |
| New York Heart Association (NYHA) Functional Class | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented. | 9 months post index procedure |
| EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. | 30 Days |
| EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. | 9 Months |
| Gurgaon |
| India |
| Rajasthan Hospital | Jaipur | India |
| Seth GS Medical College & KEM Hospital | Mumbai | India |
| Vardhman Mahavir Medical College & Safdarjung Hospital | New Delhi | India |
| Christian Medical College & Hospital | Vellore | India |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| NYHA Functional Class | NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV. | Count of Participants | Participants |
|
| EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. | Mean | Standard Deviation | Scores on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | Myocardial Infarction Rate | Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Patients were only analyzed if they did not have a permanent pacemaker at baseline. Patients who already had a permanent pacemaker implanted prior to undergoing a study procedure were excluded from this analysis. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | Percentage of Subjects With Implant Success | Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery | Posted | Count of Participants | Participants | During procedure |
|
|
|
| Primary | Echocardiographic Assessment of the Mean Aortic Gradient | Units=mmHg | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have mean gradient assessed are not presented. | Posted | Mean | Standard Deviation | mmHg | 30 days post index procedure |
|
|
|
| Primary | Echocardiographic Assessment of Effective Orifice Area (EOA) | units = cm2 | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have EOA assessed are not presented. | Posted | Mean | Standard Deviation | cm2 | 30 days post index procedure |
|
|
|
| Primary | Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days. | Reported as either none/trace, mild, moderate, or severe | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have paravalvular leak assessed are not presented. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 9 months post index procedure |
|
|
|
| Primary | VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. | Posted | Count of Participants | Participants | 9 months post index procedure |
|
|
|
| Primary | New York Heart Association (NYHA) Functional Class | Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV. | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented. | Posted | Count of Participants | Participants | 30 days post index procedure |
|
|
|
| Primary | New York Heart Association (NYHA) Functional Class | Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented. | Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV. | Posted | Count of Participants | Participants | 9 months post index procedure |
|
|
|
| Primary | EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. | Posted | Mean | Standard Deviation | Score on a scale | 30 Days |
|
|
|
| Primary | EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. | Posted | Mean | Standard Deviation | Score | 9 Months |
|
|
|
| 20 |
| 7 |
| 20 |
| 10 |
| 20 |
| EG001 | Navitor Valve | Patients implanted with Navitor Valve | 0 | 10 | 1 | 10 | 7 | 10 |
| Cardiac performation | Cardiac disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Valve mirgation | Cardiac disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Left bundle branch block | Cardiac disorders | Non-systematic Assessment |
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| Bilateral lower limb pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bleeding (per rectum) | Gastrointestinal disorders | Non-systematic Assessment |
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| Blood transfusion | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Decreased appetite | General disorders | Non-systematic Assessment |
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| Fracture in femur | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| HBsAg reactive status | Immune system disorders | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Loose stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Vascular access site related complication | Vascular disorders | Non-systematic Assessment |
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| Vessel dissection | Vascular disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pedal edema | General disorders | Non-systematic Assessment |
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| Cough and expectoration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diabetes (poorly controlled) | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Fever and chills | General disorders | Non-systematic Assessment |
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| Supracranial palsy and dementia | Nervous system disorders | Non-systematic Assessment |
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| Sialorrhea and rigidity | General disorders | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Gastroesoopgeal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
The sponsor will have the right to publish overall study results. Investigators may publish results from their respective participating site per their discretion but only after the multi-center publication is published or 12 months have passed from the study conclusion without a multi-center publication.
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
| Class III |
|
| Class IV |
|
| Moderate |
|
| Severe |
|
| Class III |
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| Class IV |
|
| Class III |
|
| Class IV |
|