Trial Outcomes & Findings for Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis (NCT NCT00538759)

NCT ID: NCT00538759

Last Updated: 2019-10-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 21 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-10-01

Participant Flow

Participant milestones

Measure	EBRT External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Overall Study STARTED	13	8
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

Baseline characteristics by cohort

Measure	EBRT n=13 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.	Total n=21 Participants Total of all reporting groups
Age, Continuous	84.8 years STANDARD_DEVIATION 4.8 • n=5 Participants	84.3 years STANDARD_DEVIATION 4.6 • n=7 Participants	84.6 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Diabetes	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Hypertension	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Hyperlipidemia	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
History of MI	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Severe MR/MS	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Severe TR/TS	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Exertional dyspnea	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Excessive fatigue	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Syncope	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
B-Type Natriuretic Peptide (BNP)	545 pg/ml STANDARD_DEVIATION 522 • n=5 Participants	744 pg/ml STANDARD_DEVIATION 972 • n=7 Participants	620 pg/ml STANDARD_DEVIATION 710 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study was halted early due to funding shortfall. Did not reach enrollment goal

Outcome measures

Measure	EBRT n=10 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=7 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
Aortic Valve Area as a Continuous Variable, Measured by Echocardiography	0.64 cm^2 Standard Error 0.06	0.72 cm^2 Standard Error 0.07

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	EBRT n=13 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
Incidence of Major External Beam Radiation Therapy-related Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Improvement from pre-procedural NYHA class. Patients' heart failure were graded according to the severity of their symptoms. The New York Heart Association (NYHA) Functional Classification was used. It places patients in one of four categories based on how much they are limited during physical activity.

I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Outcome measures

Measure	EBRT n=11 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=5 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
NYHA Improvement	6 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EBRT n=13 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
CHF Rehospitalization	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EBRT n=13 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
Aortic Valve Reintervention	8 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Study was halted early due to funding shortfall. Did not reach enrollment goal

The difference between the Aortic Valve Area at 6 months and the Aortic Valve Area post procedure indexed to the subject

Outcome measures

Measure	EBRT n=10 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=7 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
Aortic Valve Area Late Loss Index	78.8 cm^2 Standard Error 13.6	40.7 cm^2 Standard Error 16.2

SECONDARY outcome

Timeframe: 6 months

Population: Study was halted early due to funding shortfall. Did not reach enrollment goal

Outcome measures

Measure	EBRT n=10 Participants External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=7 Participants Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. Sham Control
Aortic Valve Mean Gradient	48.6 mmHg Standard Error 3.9	39.8 mmHg Standard Error 4.6

Adverse Events

EBRT

Serious events: 12 serious events

Other events: 13 other events

Deaths: 8 deaths

Control

Serious events: 7 serious events

Other events: 8 other events

Deaths: 3 deaths

Serious adverse events

Measure	EBRT n=13 participants at risk External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 participants at risk Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 3 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Arrhythmia	23.1% 3/13 • Number of events 3 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 2 • Adverse events were collected out to two years
Cardiac disorders Aortic Valve Replacement	23.1% 3/13 • Number of events 3 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Balloon Valvuloplasty	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Bleed	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Cancer	7.7% 1/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Congestive Heart Failure Exacerbation	38.5% 5/13 • Number of events 10 • Adverse events were collected out to two years	37.5% 3/8 • Number of events 3 • Adverse events were collected out to two years
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Musculoskeletal and connective tissue disorders Fatigue/Weakness	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Hepatic Ischemia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypoglycemia	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypokalemia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hyponatremia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Hypotension	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
General disorders Multi-system Organ Failure	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Non-cardiac Chest Pain	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Pneaumothorax	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Renal and urinary disorders Acute Renal Failure	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Respiratory/COPD	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Aortic Valve Restenosis	23.1% 3/13 • Number of events 4 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Musculoskeletal and connective tissue disorders Vertebraplasty	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years

Other adverse events

Measure	EBRT n=13 participants at risk External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	Control n=8 participants at risk Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Respiratory, thoracic and mediastinal disorders Dyspnea	53.8% 7/13 • Number of events 10 • Adverse events were collected out to two years	62.5% 5/8 • Number of events 6 • Adverse events were collected out to two years
General disorders Edema	53.8% 7/13 • Number of events 8 • Adverse events were collected out to two years	37.5% 3/8 • Number of events 4 • Adverse events were collected out to two years
General disorders Fatigue/Weakness	46.2% 6/13 • Number of events 9 • Adverse events were collected out to two years	50.0% 4/8 • Number of events 4 • Adverse events were collected out to two years
General disorders Non-Cardiac Chest Pain	30.8% 4/13 • Number of events 9 • Adverse events were collected out to two years	50.0% 4/8 • Number of events 6 • Adverse events were collected out to two years
General disorders Abrasion	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Aches	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Anemia	30.8% 4/13 • Number of events 5 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 2 • Adverse events were collected out to two years
Cardiac disorders Arrhythmia	23.1% 3/13 • Number of events 4 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Atrial Enlargement	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Bleed	23.1% 3/13 • Number of events 3 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Musculoskeletal and connective tissue disorders Bone Fracture	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Cardiomegaly	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Congestive Heart Failure	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 3 • Adverse events were collected out to two years
Gastrointestinal disorders Constipation/Fecal Impaction	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Chest Pain/Angina	23.1% 3/13 • Number of events 4 • Adverse events were collected out to two years	37.5% 3/8 • Number of events 4 • Adverse events were collected out to two years
General disorders Cramping	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Dehydration	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Diaphoresis	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 2 • Adverse events were collected out to two years
General disorders Dizzy/Lightheaded	15.4% 2/13 • Number of events 4 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 2 • Adverse events were collected out to two years
Blood and lymphatic system disorders Ecchmyosis	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
General disorders Fever	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Renal and urinary disorders Groin Pain	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	37.5% 3/8 • Number of events 3 • Adverse events were collected out to two years
General disorders Headache	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 4 • Adverse events were collected out to two years
Cardiac disorders Heart Murmur	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Gastrointestinal disorders Ulcer	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hematoma	30.8% 4/13 • Number of events 5 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hemoptysis	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hyperglycemia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hyperkalemia	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypertension	23.1% 3/13 • Number of events 4 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypoglycemia	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypokalemia	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	25.0% 2/8 • Number of events 2 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypomagnesemia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypotension	46.2% 6/13 • Number of events 6 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 2 • Adverse events were collected out to two years
Blood and lymphatic system disorders Hypoxemia	15.4% 2/13 • Number of events 3 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Inflamation	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Musculoskeletal and connective tissue disorders Knee Replacement	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Leukocytosis	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Luekopenia	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Psychiatric disorders Mental Status Change	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Renal and urinary disorders Urinary Issues	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Renal and urinary disorders Urinary Tract Infection	30.8% 4/13 • Number of events 4 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Blood and lymphatic system disorders Orthostatic Hypotension	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Palpitations	7.7% 1/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Cardiac disorders Pulmonary Embolism	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Pacemaker Generator Change	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Pneumonia	15.4% 2/13 • Number of events 2 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Respiratory/COPD	53.8% 7/13 • Number of events 10 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Respiratory, thoracic and mediastinal disorders Sinus Infection	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
Renal and urinary disorders Hyperdense Renal Lesions	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Blood and lymphatic system disorders Thrombocytopenia	7.7% 1/13 • Number of events 2 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Gastrointestinal disorders Upset Stomach/Vomit	15.4% 2/13 • Number of events 4 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years
Cardiac disorders Worsening Aortic Stenosis	7.7% 1/13 • Number of events 1 • Adverse events were collected out to two years	0.00% 0/8 • Adverse events were collected out to two years
General disorders Decreased Motor Function	0.00% 0/13 • Adverse events were collected out to two years	12.5% 1/8 • Number of events 1 • Adverse events were collected out to two years

Additional Information

Lisa Tindell, Director of Clinical Operations

Minneapolis Heart Institute Foundation

Phone: 6128633816

Email: Lisa.Tindell@allina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place