Trial Outcomes & Findings for A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure (NCT NCT01818765)

Results Overview

Acute: coronary arterial damage; tamponade or effusion; acute lead displacement; peri-procedural systemic thromboembolism; arrhythmia; bleeding Chronic: systemic thromboembolism; lead displacement, dysfunction or fracture; system infection; bleeding; arrhythmia; death

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Procedure 20 patients were recruited, 15 with failed transvenous LV (left ventricular) lead placement and 5 non-responders to CRT (cardiac resynchronisation therapy) .
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Procedure 20 patients were recruited, 15 with failed transvenous LV (left ventricular) lead placement and 5 non-responders to CRT (cardiac resynchronisation therapy) .
Overall Study Death	2

Baseline Characteristics

A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Procedure n=20 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants
Electrocardiogram QRS segment duration	157 ms STANDARD_DEVIATION 14 • n=5 Participants
ischaemic aetiology	9 Participants n=5 Participants
Ejection fraction	28 % (of blood ejected from left ventricle) STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Acute: coronary arterial damage; tamponade or effusion; acute lead displacement; peri-procedural systemic thromboembolism; arrhythmia; bleeding Chronic: systemic thromboembolism; lead displacement, dysfunction or fracture; system infection; bleeding; arrhythmia; death

Outcome measures

Outcome measures
Measure	Procedure n=20 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Number of Participants Free of Adverse Effects at 6 Months Post Procedure	15 Participants

SECONDARY outcome

Timeframe: 6 months

Ability to successfully deliver LV endocardial pacing via the ventricular transseptal approach (procedure success rate)

Outcome measures

Outcome measures
Measure	Procedure n=20 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Procedural Success - Number of Participants With Successful Delivery of Left Ventricular Lead Via Ventricular Transseptal Approach	20 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Those patients who attended follow-up at six months were analysed

Improvement in New York Heart Association (NYHA) functional class by \>=1 NYHA functional class is a very widely used measure of symptoms in heart failure. Improvement is considered to be a decrease in class, representing improve symptoms Class Patient Symptoms 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

Outcome measures
Measure	Procedure n=18 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
NYHA Class	9 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Those patients who attended follow-up at six months and completed the questionnaires were analysed

Change in quality of life as measured using the EQ-5D-5L (EuroQol five dimension, five level score ) tool (\>1 point decrease) The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number from 1 to 5 that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Increase in score for each dimension represent worsening of symptoms/ problems

Outcome measures

Outcome measures
Measure	Procedure n=16 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Number of Participants With >1 Point Improvement in EQ-5D-5L Quality of Life Score	9 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Change in 6 minute walk distance; ≥10% increase

Outcome measures

Outcome measures
Measure	Procedure n=16 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Number of Participants With ≥10% Increase in 6-minute Walk Distance	10 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Those patients who attended follow-up at six months and had an echocardiogram with interpretable data were analysed

Change in echocardiographic parameters of cardiac function ejection fraction was measured using two-dimensional echocardiography and the Simpson method at baseline and six months

Outcome measures

Outcome measures
Measure	Procedure n=16 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Echocardiographic Response: Change in Ejection Fraction as Measured by Echocardiography From Baseline to 6 Months	41 % cardiac ejection fraction Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Those patients who attended follow-up at six months and had both baseline and six month BNP results available were analysed

Change in BNP (b-type natriuretic peptide) levels BNP levels were measured from a standard blood draw at baseline and six months.

Outcome measures

Outcome measures
Measure	Procedure n=13 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Biochemical Response: Change in BNP (B-type Natriuretic Peptide) Levels Between Baseline and Six Months	95 pmol/L Standard Deviation 129

SECONDARY outcome

Timeframe: 2 years

Population: Those patients who had follow-up available for any time period more than three months were included

Systemic thrombosis at 2 years

Outcome measures

Outcome measures
Measure	Procedure n=18 Participants 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Clinical Outcomes	3 Participants

Adverse Events

Procedure

Serious events: 3 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Procedure n=20 participants at risk；n=18 participants at risk 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Nervous system disorders Stroke or transient ischaemic attack	16.7% 3/18 • Number of events 3

Other adverse events

Other adverse events
Measure	Procedure n=20 participants at risk；n=18 participants at risk 20 patients were recruited, 15 with failed transvenous LV lead placement and 5 non-responders to CRT.
Injury, poisoning and procedural complications wound haematoma, requiring early re-operation	10.0% 2/20 • Number of events 2

Additional Information

Dr James Gamble

Oxford university hospitals NHS Foundation Trust

Phone: +441865221012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place